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 2019-12-16 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[175237620]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175237621]
Physician used a venaseal kit during treatment of the patient? S great saphenous vein (gsv). Ifu was followed. A guidewire was used for insertion of the catheter. It is reported that midway through the procedure the gun could no longer dispense glue. The procedure is reported to be partially completed. It is unknown if additional treatment was required. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188148127]
Product analysis: components (dispenser gun, catheter and one syringe) were returned for analysis. No damage noted on the gun. A 3ml syringer was inserted with the plunger pulled back during each functional test. Due to dried glue residue in the gun interior, the plunger was only able to be pulled back to 2. 8 ml instead of 3 ml. The plunger failed to advance to the end of the syringe during three trigger tests, but after tightening the screws of the dispensing gun, the responsiveness of the trigger pulls was improved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-05182 |
| MDR Report Key | 9472948 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-16 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-02-12 |
| Date Added to Maude | 2019-12-16 |
| 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 | 2019-12-16 |
| Returned To Mfg | 2020-01-02 |
| Catalog Number | VS-402 |
| Lot Number | 54696 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-16 |