MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012454-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending artery.The 4.50x12mm nc trek balloon dilatation catheter (bdc) was inflated to 20 atmospheres for post dilatation of a previously unspecified stent.The bdc became stuck with an unspecified stent in the left main and and when attempting to remove the proximal shaft of the bdc separated.The separated portion remained stuck on the guide therefore, everything was removed as a one unit including the separate portion.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - above rated burst pressure.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational context.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported by the account that the balloon was overinflated to 20 atmospheres (atms).It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, it is unknown if inflating the balloon slightly over cause or contributed to the reported complaint.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to operational context.In this case, it is unknown if inflating the balloon slightly over cause or contributed to the reported complaint.It was reported by the account that the balloon interacted with a previously implanted stent such that difficulty was encountered.Upon further manipulation of the device during attempts to remove it, the shaft ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21969227
• Report Number: 2024168-2025-04700
• Device Sequence Number: 8350872
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: (01)08717648152108(17)270930(10)41010G1
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 41010G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown