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

Model Number	1012453-12
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 information provided, a definitive cause for the reported failure to fold could not be determined; however, the reported difficulty removing the device appears to be related to operational context.Possible factors that may contribute to a non-uniform balloon refold (failure to fold) include, but not limited to, large balloon profile, deflation technique and multiple inflations.In this case, it is possible that the combination of the larger profile of the nc trek balloons, and the reported winged balloon contributed to the resistance met with the guiding catheter, resulting in the difficulty removing the balloon dilatation catheter (bdc).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.Following dilatation with a 4.0 x 12 mm nc trek rx balloon dilatation catheter (bdc), the balloon was noted to be deformed and could not be withdrawn through the catheter.A serious injury was noted; however, no clinical delay was reported.Additional information reported that there was mild calcification in the vessel, and the balloon failed to fold during deflation after being prepared and inflated 5 times to 12 atms with no noted issues using 1:1 contrast mix.The bdc along with the guiding catheter were removed as a single unit.The procedure was completed with the use of a non-abbott device and there were no adverse patient effects reported.No additional information was provided.

• 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: 22731162
• Report Number: 2024168-2025-08131
• Device Sequence Number: 21080209
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: (01)08717648152061(17)260930(10)31027G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1012453-12
• Device Catalogue Number: 1012453-12
• Device Lot Number: 31027G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Patient Sex: Unknown