FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 143541
·
Received January 9, 1998
Report
- Report Number
- 2248146-1997-01425
- Event Type
- Malfunction
- Date Received
- January 9, 1998
- Date of Event
- December 17, 1997
- Report Date
- December 18, 1997
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 1/13/98).
Description of Event or Problem · 1
THE IAB WAS INSERTED INTO THE PT ON 12/15/97 AT 4:20 PM. POOR INFLATION AND AUGMENTATION WERE NOTED DURING IABP. THE IAB WAS REMOVED ON 12/17/97 AT 9:25 AM. THE BALLOON CATHETER WAS FOUND KINKED AT TWO PLACES UPON REMOVAL AT THE SITE AND TWO INCHES UP THE SHEATH. NO SECOND IAB WAS INSERTED. (ON 1/9/98, DATASCOPE REC'D THE VOLUNTARY FORM FROM THE FDA; TRIAGE UNIT SEQUENCE NUMBER: 74891; MDR ACCESS NUMBER: 1012679). [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 12/18/97. [PT'S CURRENT STATUS]: STABLE-RPT'D 12/18/97.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 40 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0321 | 10/17/99 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |