FDA Adverse Event
Malfunction
Summary report: N
INAHARA-PRUITT CAROTID SHUNT
MDR report key: 212787
·
Received March 8, 1999
Report
- Report Number
- 1056436-1999-00036
- Event Type
- Malfunction
- Date Received
- March 8, 1999
- Report Date
- February 9, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- DQR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 02/09/1999, THE MFR WAS INFORMED VIA A FAXED REPORT BY THE PREVIOUS OWNER OF THE MFR OF THE FOLLOWING: THE CUSTOMER INFORMED THE INTERNATIONAL DISTRIBUTOR OF THE FOLLOWING: AT TIMES, THE BALLOON EXPLODES DURING PRE-USE TEST, OR THE BALLOON EXPLODES DURING THE SURGICAL PROCEDURE EVERY TIME THERE IS A PLAQUE PRESENT IN THE VEIN. THE FAXED REPORT WAS VAGUE, BUT APPARENTLY THERE ARE FIVE (5) DEVICES (3 - LOT # 105309801, 2 - LOT #103309802) THAT ARE BEING RETURNED TO THE MFR, BUT IT IS UNCLEAR IF THESE DEVICES HAVE BEEN USED OR NOT. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INAHARA-PRUITT CAROTID SHUNT | CATHETER, CANNULA AND TUBING, VASCULAR SHUNT | DQR | HORIZON MEDICAL PRODUCTS, INC. | NA | 105309801/103309802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |