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

Model Number	1012454-08
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Angina (1710); Unspecified Tissue Injury (4559)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
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
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with no calcification, no tortuosity and 90% stenosis.The 4.5x8 mm nc trek balloon dilatation catheter was inflated once to 12 atmospheres and although negative pressure was held for 16 seconds, the device was not fully deflated.There was resistance between devices during removal and all the devices were removed as a unit with the balloon still partially inflated.This caused the stent to be dragged out.An unspecified balloon was used to complete the procedure.The patient experienced chest pain and myocardial tear injury.Local drug treatment was provided and the patient was hospitalized additional time.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 review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported deflation issue could not be determined.In this case, it is likely that the instruction for use (ifu) violation contributed to the reported difficulty removing the device and device damaged by another device resulting in user error/operational context.The reported medication required, and hospitalization appear to be related to circumstances of the procedure.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 is likely that the reported deflation issue contributed to the resistance met during removal and the interaction with the stent that resulted in the stent being dragged out.Additionally, a conclusive cause for the reported patient effects of angina and unspecified tissue injury, and the relationship to the product, if any, cannot be determined.The reported patient effect of angina is listed in the coronary dilatation catheters (cdc), nc trek, instruction for use as a known patient effect.It was reported by the account that the balloon was removed partially inflated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is likely that the instruction for use (ifu) violation contributed to the reported difficulty removing the device and device damaged by another device.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 - medical device problem code 2017 - failure to follow steps/instructions was added.

• 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: 24874694
• Report Number: 2024168-2026-01511
• Device Sequence Number: 9331850
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: (01)08717648152092(17)270831(10)40904G1
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012454-08
• Device Catalogue Number: 1012454-08
• Device Lot Number: 40904G1
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown