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

Model Number	1012455-08
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 the procedure was to treat a mildly calcified and tortuous lesion in the left anterior descending (lad) artery.A non-abbott guidewire was passed through the lesion and a 4.0x18mm stent was deployed.A 5.0x8mm nc trek balloon dilatation catheter was inflated to 12 atmospheres (atm) to post dilate the proximal portion of the stent.The balloon was fully deflated however resistance was met with the anatomy and guiding catheter during removal and during the process the shaft separated.Despite repeated attempts to snare the device, it could not be removed.The patient was transferred to surgery for removal of the balloon.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational context.The reported difficulty removing the device from the guiding catheter 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, the investigation determined that the reported difficulty removing the device, separation, unexpected medical intervention and surgical intervention appears to be related to operational context.Return device analysis noted the balloon was bunched proximal from the distal tip.In this case, it is likely that deflation technique and/or insufficient time for the balloon to fully deflate before removing it contributed to the noted bunched balloon and subsequently the reported difficulty removing the device from the anatomy and guiding catheter as this is a bigger size balloon.Additionally, it is likely that the combination of the larger profile of the 5.00 mm balloon and the bunching of the balloon contributed to the resistance met with the patient anatomy and guiding catheter resulting in the reported difficulty removing the balloon dilatation catheter (bdc) and separation during removal.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: 21864708
• Report Number: 2024168-2025-04026
• Device Sequence Number: 4721215
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: (01)08717648152139(17)270731(10)40814G1
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 40814G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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
• Patient Sex: Unknown