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

Model Number	1012455-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
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 performed to treat a heavily calcified lesion in the right coronary artery.After non-abbott stents were deployed at the target lesion, post dilatation was performed using a 5x15mm nc trek rx balloon dilatation catheter (bdc).It was noted however, after dilatation and deflation the bdc was not able to be removed, and the bdc was removed along with the guiding catheter as a single unit.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and mildly tortuous lesion in the right coronary artery.After non-abbott stents were deployed at the target lesion, post dilatation was performed using a 5x15mm nc trek rx balloon dilatation catheter (bdc).It was noted after dilatation and deflation the bdc was difficult to be removed from the stent, however, the bdc was ultimately removed along with the 6f guiding catheter as a single unit.No further treatment was needed so the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to filing the initial report, returned device analysis revealed that the inner and outer member of the bdc were separated and torn.The account was not aware of the separation or tears.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to remove 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.Based on the reported information and the observations from the returned device analysis, a definitive cause for the reported difficulty removing the device could not be determined.Returned device analysis noted that the distal shoulder area of the balloon was folded into itself, and the balloon was wrinkled across the length of the balloon.In this case, it is possible that since this is a larger balloon profile, sufficient time was not allowed to fully deflate the balloon before an attempt was made to withdraw the device resulting in the noted damage to the balloon and interaction with the stent which subsequently resulted in the reported difficulty removing the device from the stent; however, a conclusive cause cannot be determined.Based on the results of the complaint investigation 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20440554
• Report Number: 2024168-2024-12076
• Device Sequence Number: 20873917
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: (01)08717648152153(17)260228(10)30308G1
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/25/2024

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 Expiration Date: 02/28/2026
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 30308G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.MM AND 4.5MM ONYX (MEDTRONIC); GUIDING CATHETER
• Patient Sex: Unknown