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

Model Number	1012453-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 performed to treat a lesion in the moderately calcified left anterior descending coronary artery.A 4x20mm nc trek balloon dilatation catheter (bdc) was advanced without resistance, and the balloon was inflated once to 24 atmospheres.However, the balloon only partially deflated within the unspecified stent.The partially deflated balloon was retracted into the guide catheter with resistance and force applied.The shaft of the bdc separated, so the whole system was removed.A non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported deflation problem and reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.It should be noted that the nc trek rx coronary dilatation catheter instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp).Additionally, it should be noted that the nc trek rx coronary dilatation catheter instructions for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The complaint investigation determined the reported difficulties are related to a manufacturing issue associated with deflation issues.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 10079390
• Report Number: 2024168-2020-04457
• Device Sequence Number: 17076650
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 00121G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1