FDA Adverse Event
Malfunction
Summary report: N
ANGIO-SEAL
MDR report key: 224728
·
Received May 21, 1999
Report
- Report Number
- 3032312-1999-00103
- Event Type
- Malfunction
- Date Received
- May 21, 1999
- Date of Event
- April 9, 1999
- Report Date
- April 22, 1999
- Manufacturer
- DAIG, A ST. JUDE MEDICAL CO
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 04/09/1999, FOLLOWING A PTCA PROCEDURE, A ANGIO-SEAL DEVICE WAS PLACED IN A PT'S GROIN. REPORTEDLY, DURING DEPLOYMENT, THE SUTURE WAS BROKEN ABOVE THE ANCHOR, AND THE SUTURE AND COLLAGEN WERE REMOVED FROM THE PUNCTURE TRACT WITHOUT THE ANCHOR. THE DISTAL PULSE NOTED TO BE "OK" WITH NO COMPLAINT OF PAIN FROM THE PT, OR ADD'L SEQUELAE. AS OF 05/19/1999 THERE HAS BEEN NO FURTHER REPORT TO THE MFR OF COMPLICATION OR ADD'L PT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIO-SEAL Implant | HEMOSTATIC PUNCTURE CLOSURE DEVICE | MGB | DAIG, A ST. JUDE MEDICAL CO | NA | 101579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |