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

Model Number	1012453-08
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nmpa report number is (b)(4).It was reported that the procedure was performed to treat a mildly calcified and tortuous lesion in the left anterior descending (lad) artery.A 4 x 8 mm nc trek balloon dilatation catheter (bdc) was used at the lesion and inflated 1-2 times to 16 atms and completely deflated; however, during the withdrawal resistance was felt.After the device was removed with force, the balloon was noted to be broken [ruptured].Therefore, a non-abbott device was used to complete the procedure.There were no reported adverse patient effects nor clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 (against resistance).
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported balloon rupture could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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.It was reported by the account that force had to be used to remove the balloon from the anatomy as resistance was encountered.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), stated: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is unlikely that the ifu deviation contributed to the reported complaint and had to happen given the clinical situation.Based on the reported information and the observations from the returned device analysis, a definitive cause for the reported balloon rupture could not be determined; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.In this case, it is unlikely that the instructions for use (ifu) deviation contributed to the reported complaints and had to happen given the clinical situation.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, insufficient prep, interactions with other devices or lesion calcification.A conclusive cause for the reported balloon rupture could not be determined; however, it is likely that the reported balloon rupture contributed to the reported difficulty removing the device as the balloon likely did not refold to it intended stated due to the rupture.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: 21859104
• Report Number: 2024168-2025-03974
• Device Sequence Number: 12734650
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: (01)08717648152054(17)270831(10)40928G1
• 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
• Report Date (Section B): 05/13/2025

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: 1012453-08
• Device Catalogue Number: 1012453-08
• Device Lot Number: 40928G1
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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