FDA Adverse Event
Malfunction
Summary report: N
PERCOR STAT DL 9.5 FR. 40 CC IAB
MDR report key: 49376
·
Received September 20, 1996
Report
- Report Number
- 2242850-1996-00088
- Event Type
- Malfunction
- Date Received
- September 20, 1996
- Date of Event
- August 30, 1996
- Report Date
- September 3, 1996
- Manufacturer
- DATASCOPE CORPORATION
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FORM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER. UNDERWATER LEAK TESTING REVEALED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. THE PENETRATION WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. DEVICE LABELLING CODE: 1738.
Description of Event or Problem · 1
THE IAB LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCOR STAT DL 9.5 FR. 40 CC IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORPORATION | 0684-00-0211-01 | 05/26/98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |