FDA Adverse Event
Malfunction
Summary report: N
MEDICHOICE VESSEL LOOP
MDR report key: 1738335
·
Received June 21, 2010
Report
- Report Number
- 1836161-2010-00001
- Event Type
- Malfunction
- Date Received
- June 21, 2010
- Date of Event
- April 1, 2010
- Report Date
- June 16, 2010
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- KDC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE COULD NOT BE EVALUATED AS IT WAS NOT RETURNED. NO OTHER COMPLAINT FOR THE BREAKAGE HAVE BEEN REPORTED IN MORE THAN THREE YEARS. THE LOT NUMBER FOR DEVICE THAT REPORTEDLY FAILED IS UNK. A DEVICE FROM A LOT STILL IN INVENTORY IS IN THE PROCESS OF BEING EVALUATED. THIS FAILURE IS A TYPICAL AND, UNTIL AN EVALUATION IS COMPLETE, THE ROOT CAUSE IS UNK.
Description of Event or Problem · 1
VESSEL LOOP BROKE WHILE BEING USED TO OCCLUDE A CAROTID ARTERY. NO SERIOUS ISSUES RESULTED FROM THE FAILURE. THE DOCTOR COMPLETED THE PROCEDURE AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDICHOICE VESSEL LOOP | VESSEL LOOP | KDC | ASPEN SURGICAL PRODUCTS, INC. | LOOP2002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |