FDA Adverse Event
Malfunction
Summary report: N
ANGIO-SEAL
MDR report key: 226788
·
Received June 2, 1999
Report
- Report Number
- 3032312-1999-00111
- Event Type
- Malfunction
- Date Received
- June 2, 1999
- Date of Event
- May 3, 1999
- Report Date
- May 4, 1999
- Manufacturer
- DAIG, A ST. JUDE MEDICAL CO.
- Product Code
- MGB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 06/03/1999 FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S RIGHT GROIN. REPORTEDLY, DURING THE DEPLOYMENT SEQUENCE THE WHOLE DEVICE CAME OUT OF THE PUNCTURE TRACT. UPON INSPECTION OF THE DEVICE BY THE STAFF, THE ANCHOR WAS NOTED TO BE CRACKED. MANUAL PRESSURE WAS HELD FOR AN UNKNOWN PERIOD OF TIME, WITHOUT ANY PATIENT SEQUELAE NOTED. AS OF 06/01/1999, THERE HAS BEEN NO FURTHER REPORT TO THE MANUFACTURER OF COMPLICATION OR ADDITIONAL PATIENT 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 | 100856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |