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 2020-01-31 for FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER G406986 manufactured by St. Jude Medical.
[187720466]
One fast-cath transseptal guiding introducer was received for investigation. A leak was noted at the hemostasis valve during functional testing. The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected. Tearing, resulting in a hole, was noted on the distal face of the seal, at both ends of the seal slit. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the torn seal and subsequent leak is consistent with damage during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005334138-2020-00032 |
| MDR Report Key | 9653589 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-04-10 |
| Date Added to Maude | 2020-01-31 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL (AFD-PLYMOUTH) |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER |
| Generic Name | CATHETER, INTRODUCER |
| Product Code | GXD |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-02-07 |
| Model Number | G406986 |
| Lot Number | 6945817 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |