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

Model Number	1012454-12
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Fold (1255); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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.
Event or Problem Description
The nmpa report number is (b)(4).It was reported that the procedure was to treat the right coronary artery (rca) with 90% stenosis.After angioplasty, the 4.5x12 mm nc trek balloon dilatation catheter (bdc) could not re-fold and had resistance with the guiding catheter during removal.Multiple instruments were used to ultimately remove the balloon with the guiding catheter.The procedure was prolonged but there was no harm to the patient.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed reports it was stated that no additional devices were used to help remove the balloon.The balloon was removed as a unit with the guiding catheter.No additional information was provided.
Additional Manufacturer Narrative
B1: adverse event was removed.B2: required intervention was removed.B5: describe event or problem: revised h1: type of reportable event updated from serious injury to malfunction.H6: health effect - impact code 4641 was removed h6: medical device problem code 1212 was removed.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported complaints could not be determined.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.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use, states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.Choosing a larger guiding catheter size may minimize this.In this case, it is possible that the combination of the larger profile of the nc trek balloons, and the reported failure to fold balloon contributed to the resistance met with the guiding catheter, resulting in the difficulty removing the balloon dilatation catheter (bdc); however, a conclusive cause cannot be determined since the device was not returned for analysis.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: 23811730
• Report Number: 2024168-2025-12052
• Device Sequence Number: 7686360
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: (01)08717648152108(17)280531(10)50624G1
• 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,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 50624G1
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/13/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown