NC TREK CORONARY DILATATION CATHETER
Report
- Report Number
- 2024168-2022-12748
- Event Type
- Injury
- Date Received
- December 16, 2022
- Date of Event
- December 6, 2022
- Report Date
- January 25, 2023
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- LOX
- PMA / PMN Number
- K103153
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO DEFLATE; HOWEVER, THE REPORTED UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.
D4- THE PART NUMBER WAS UPDATED FROM UNK NC TREK OTW TO UNK NC TREK. G4 - PMA/510(K) UPDATED FROM K103110 TO K103153.
IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, DURING USE OF AN NC TREK BALLOON DILATATION CATHETER (BDC), THE BALLOON WAS UNABLE TO DEFLATE. A GUIDEWIRE WAS USED TO PUNCTURE THE BALLOON IN ORDER TO DEFLATE AND REMOVE THE BALLOON. THERE WAS NO REPORT OF ANY ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2700864 | NC TREK CORONARY DILATATION CATHETER | CORONARY DILATATION CATHETER | LOX | ABBOTT VASCULAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |