MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-03 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[177539687]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177539688]
Physician intended to use a venaseal kit during treatment of the patient? S great saphenous vein (gsv). Ifu was followed. The physician flushed the blue venaseal introducer and left the syringe attached. During the prep and priming of the venaseal delivery catheter the physician noted the blue venaseal introducer would not flush again. The elapsed time between when the blue introducer was flushed to when it would not flush was about 1-2 minutes. The primed delivery catheter was inserted into the blue venaseal introducer with noted resistance. A clot was identified in the shape of the blue introducer along the proximal gsv through the saphenofemoral junction (sfj) into the common femoral vein. The venaseal delivery catheter with the attached blue introducer were removed from the patient. The 7 fr. Sheath was removed from the patient. Pressure was held to achieve haemostasis. A dry sterile dressing was applied. When the patient started to walk around the bleeding continued, pressure was applied, and haemostasis was achieved again. The initial dressing was saturated with blood and replaced with another dry sterile dressing. The procedure was aborted, and the physician prescribed eliquis to the patient for a 7-day course. The patient is scheduled to return for follow up next week. It will be determined at follow up if the clot has resolved to reschedule the patient for the venaseal procedure.
Patient Sequence No: 1, Text Type: D, B5
[182473416]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586331]
Product analysis: the venaseal device was returned within a saftpak biohazard pouch and within a clear biohazard bag. Blood residue was observed on all the returned components. The catheter tip was occluded with dried adhesive. Blood residue was observed on the entire catheter shaft. No physical damage was noted on the catheter. The blue introducer was occluded with blood residue within its lumen. Due to the occlusion of the introducer, a known good catheter from analysis lab cannot be inserted within the introducer. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586558]
Additional information: the procedure was aborted during an attempt to treat the left great saphenous vein (gsv) with venaseal. No adhesive was administered to the patient. Patient had a follow up consultation approximately 4 weeks after the procedure. There is no ultrasound evidence of the suspicious area of the clot. The gsv in the left lower extremity of the leg has occluded, but the upper vessel remains incompetent and open. No presence of edema. There is still some heaviness in the left leg, but this is not debilitating. There is no walking related complaints compatible with claudication. Patient is in good health with no major medical or surgical problems. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00520 |
| MDR Report Key | 9659116 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-09-25 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENA SEAL CLOSURE SYSTEM |
| Generic Name | AGENT, OCCLUDING, VASCULAR, PERMANENT |
| Product Code | PJQ |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2020-02-28 |
| Model Number | VS-402 |
| Catalog Number | VS-402 |
| Lot Number | 57181 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-03 |