FDA Adverse Event
Injury
Summary report: N
6000089-1999-00116
MDR report key: 257226
·
Received December 29, 1999
Report
- Report Number
- 6000089-1999-00116
- Event Type
- Injury
- Date Received
- December 29, 1999
- Date of Event
- November 19, 1999
- Report Date
- December 8, 1999
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED DURING A PTCA PROCEDURE, THE SHAFT OF THE CATHETER BROKE AND WAS REMOVED WITHOUT INCIDENT. NO PT INJURIES OR COMPLICATIONS OCCURRED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |