MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012455-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the popliteal artery.During the procedure, the 5.00x20 mm nc trek balloon dilatation catheter (bdc) had problems with deflation and could only partially deflate.The bdc was inflated to 16 atmospheres three times and negative pressure was held for 1 minute.The bdc was removed partially inflated.An unspecified stent was used to complete the procedure.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported deflation issue and difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the noted stretched outer member at the mid lap seal and reported deflation issue appears to be related to a potential product quality issue.The reported separation and difficulty removing the device appears to be related to circumstances of the procedure.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.E1: facility name and address, city, postal code updated from the distributor to the hospital information.
Event or Problem Description
Subsequent to the initially filed report, the returned device analysis identified that the shaft was separated at the guide wire exit notch and the proximal portion was not returned.Follow-up with the account confirmed that they were aware of the separation and the separated portion was discarded.Additionally, it was reported that the nc trek balloon was repositioned during inflations/deflations and only after the third inflation/deflation did the balloon fail to deflate.There was resistance with the guide catheter during removal of the nc trek catheter.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11319151
• Report Number: 2024168-2021-01140
• Device Sequence Number: 3691899
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• Combination Product (Y/N): N
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Device Lot Number: 00109G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1