FDA Adverse Event
Malfunction
Summary report: N
CROSSBOSS
MDR report key: 3638694
·
Received February 17, 2014
Report
- Report Number
- 3638694
- Event Type
- Malfunction
- Date Received
- February 17, 2014
- Date of Event
- January 10, 2014
- Report Date
- February 17, 2014
- Manufacturer
- BRIDGEPOINT MEDICAL, INC. A SUBSIDIARY OF BSC
- Product Code
- LOX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
CATHETER WAS KINKED AT DISTAL END OF CATHETER; DISCOVERED UPON OPENING PACKAGE. ONE ATTEMPT TO LOAD ON THE WIRE FAILED. THE WIRE DID NOT PASS THROUGH THE LUMEN AT THE LOCATION OF THE KINK. THE CATHETER WAS PUT TO THE SIDE AND ANOTHER CROSS BOSS WAS OPENED. THE BOX UPON INSPECTION DID NOT APPEAR DAMAGED. SMALL PROCEDURE DELAY FOR PATIENT.====================== MANUFACTURER RESPONSE FOR CROSS BOSS CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER).====================== PROVIDED NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100039 | CROSSBOSS | CATHETER, PERCUTANEOUS | LOX | BRIDGEPOINT MEDICAL, INC. A SUBSIDIARY OF BSC | * | 8132130144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |