MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012455-08
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery.After post-dilatation of an implanted stent with a 5x8mm nc trek balloon and during removal of the balloon, resistance was met with the anatomy.Due to the resistance, the distal shaft broke in two pieces.The physician attempted to pull back the separated distal shaft with the guide wire and pull it back in the guide catheter to get it back in the sheath.However, the separated distal shaft did not go through the sheath and therefore another guide wire had to be inserted, advanced to the side to pull the separated distal shaft into the sheath and it was then able to be ultimately removed as a single unit.It was confirmed that the nc trek balloon was fully deflated before removal.The procedure completed successfully at this point.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it is likely that the balloon dilatation catheter (bdc) interacted with the patient¿s anatomy during removal, resulting in the reported entrapment of the balloon within the vessel.Manipulation of the device against resistance likely resulted in the reported material separation.The separated portion of the bds was removed using a guide wire.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 15727331
• Report Number: 2024168-2022-11233
• Device Sequence Number: 16862160
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: 03/31/2025
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 20420G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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