MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-23 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.
[176412958]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176412959]
Physician used venaseal occluding device during procedure to treat 15cm of the great saphenous vein (gsv). Ifu was followed during preparation, procedure and post procedure. A guide wire was used for the insertion of the catheter. It was reported that the bilateral venaseal scheduled for the patient, tor the treatment of the left gsv was done with no issues observed. Glue catheter was removed from left leg, tip was wiped clean with a clean dry gauze. Same catheter was used for right gsv. When administering the 1st dose 6cm away from the sfj, plunger in the syringe did not move, although gun leaver was pressed firmly and held for 3 secs. Compression was maintained with an ultrasound transducer. Physician repeatedly administered 2 more doses at the same spot but, plunger did not move. A new kit from the same lot was opened. The procedure was completed with a gun and syringe of glue per ifu. 30 - 35 minutes post-procedure ultrasound scan showed that cfv near the sfj was 20% occluded with 0. 3mls glue, about 1 cm long segment. The procedure was converted from endo to open procedure to remove hardened glue from cfv near the sfj. No further patient injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[181860604]
Post procedure ultrasound scan was carried out 30 - 45 minutes post-procedure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-05286 |
| MDR Report Key | 9509182 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-23 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-05-07 |
| Date Added to Maude | 2019-12-23 |
| 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 | 2019-12-23 |
| Model Number | SP-101 |
| Catalog Number | SP-101 |
| Lot Number | 55676 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-12-23 |