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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left main stem (lms) to left anterior descending (lad) coronary arteries with 70% stenosis in the lms and calcification and 80% stenosis in the lad.The target lesion was treated with intravascular lithotripsy (ivl).The 5.0x8 mm nc trek balloon dilatation catheter was advanced to the target lesion without difficulty.The nc trek balloon was inflated and deflated without issue; however, during withdrawal, the balloon caught on the proximal edge of an unspecified stent.Slight force was applied and the nc trek balloon separated.An attempt was made to retrieve the separated segment using an unspecified 2.5x1.5 mm device in the guiding catheter; however, this was unsuccessful.A non-abbott snare device was then used to successfully retrieve the separated balloon segment.The procedure continued with a second unspecified nc dilatation catheter.There was no adverse patient sequela.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.
Additional Manufacturer Narrative
The device was not returned for evaluation.The production record and corrective and preventive 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 since resistance was met during attempts to remove the device, slight force was applied and the bdc separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use ifu, states: 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.The investigation determined the reported difficulty removing the device and unexpected medical intervention appear to be related to operational context and the reported separation appears to be related to user error/operational context.It was reported by the account that during withdrawal, the balloon caught on the proximal edge of an unspecified stent.Slight force was applied, and the nc trek balloon separated.An attempt was made to retrieve the separated segment using an unspecified device in the guiding catheter; however, this was unsuccessful.A non-abbott snare device was then used to successfully retrieve the separated balloon segment.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 was added for use of excessive force.Corrections: d9 - device available for evaluation: updated from "yes" to "no".

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18923470
• Report Number: 2024168-2024-03433
• Device Sequence Number: 7477065
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: (01)08717648152139(17)250531(10)20613G1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 20613G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• 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