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

Model Number	1012454-12
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, mildly tortuous left anterior descending coronary artery that is 80% stenosed.The 4.50x12mm nc trek balloon dilatation catheter completely failed to deflate, was withdrawn partially deflated, and the shaft was noted to be cracked.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.It was reported by the account that the balloon was removed partially inflated.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is unknown if the instruction for use (ifu) violation caused or contributed to the reported complaint.Based on the information provided, a definitive cause for the reported complaints could not be determined.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, a conclusive cause for the reported deflation issue could not be determined since the device was not returned for analysis.Additionally, it was reported that the shaft was noted to be cracked after removal.In this case, it is possible that the reported crack was likely what the account perceived as a possible kink, break or shaft separation, which likely resulted from manipulation of the device during removal as the deflation issue was noted; however, this cannot be confirmed since the device was not retuned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - incorrect removal.

• 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: 23584916
• Report Number: 2024168-2025-11583
• Device Sequence Number: 18524772
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: (01)08717648152108(17)271031(10)41113G1
• 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
• Report Date (Section B): 11/18/2025

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: 41113G1
• 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: 11/03/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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