FDA Adverse Event
Injury
Summary report: N
6000089-1999-00115
MDR report key: 257242
·
Received December 29, 1999
Report
- Report Number
- 6000089-1999-00115
- Event Type
- Injury
- Date Received
- December 29, 1999
- Report Date
- December 8, 1999
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PTCA PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE CATHETER TO THE LESION. WHILE ATTEMPTING TO REPOSITION THE CATHETER, THE SHAFT BROKE AND A SEGMENT REMAINED IN THE ARTERY AND GUIDE CATHETER. ATTEMPTS AT RETRIEVAL WERE UNSUCCESSFUL AND PT WAS SENT TO SURGERY. PT STATUS IS LISTED AS "OKAY".
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |