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

Model Number	1012454-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the right coronary artery.The 4.50x20mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and inflated to 16 atmospheres.During removal resistance was met with the 6fr guiding catheter and the balloon appeared deformed.The bdc, guiding catheter, and guide wire had to be removed as one unit.There were 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.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty could not be replicated in a testing environment due to the condition of the returned device.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, a definitive cause for the reported difficulty removing the device could not be determined.Returned device analysis noted that the distal end of the balloon was wrinkled.In this case, it is possible that since this is a larger balloon profile, sufficient time was not allowed to fully deflate the balloon before an attempt was made to withdraw the device resulting in the noted wrinkled balloon and interaction with the guiding catheter which subsequently resulted in the reported difficulty removing the device; however, a conclusive cause cannot be determined.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 00000 ; CS 00000
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21313981
• Report Number: 2024168-2025-01319
• Device Sequence Number: 8169437
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: (01)08717648152122(17)261031(10)31103G1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 31103G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDING CATHETER
• Patient Sex: Unknown