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

Model Number	1012452-12
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.The 3.75x12 mm nc trek balloon dilatation catheter (bdc) ruptured during the first inflation at 14 atmospheres.A 3.75x15 mm nc trek bdc was inflated three times to 12 atmospheres; the balloon only partially deflated.The bdc was removed partially deflated.A non-abbott device was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and sem analysis were performed on the returned device.The reported leak and difficulty were confirmed.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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to circumstances of the procedure.Return device analysis noted the inner member, inside the balloon and distal balloon marker were torn.In this case, it is possible that the bdc was inadvertently mishandled during advancement and/or repositioned during the procedure such that the inner member and marker became stretched/damaged.Upon inflation the stretched/weakened material ruptured/tore which resulted in the reported leak.Additionally, it is likely that the bdc interacted with the guiding catheter during removal resulting in the reported difficulty.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the inner member exhibited a leak in a stretched/necked marker region.The inner member failure may be attributed to mechanical damage initiating from the inner surface of the inner member.The damage was located at and adjacent to the edge of the leak.It is uncertain whether the necking contributed to the failure mechanism, the stretched/necked area may be attributed to exposure conditions and/or handling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated.H6: medical device problem code 1546 removed.
Event or Problem Description
Subsequent to the initially filed report it was stated the 3.75x12 mm nc trek had resistance during removal with the [guiding] catheter.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21142552
• Report Number: 2024168-2025-00512
• Device Sequence Number: 9097255
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: (01)08717648152023(17)270228(10)40325G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110134
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 1012452-12
• Device Catalogue Number: 1012452-12
• Device Lot Number: 40325G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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