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

Model Number 1012455-08

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 303046031
• Report Number: 2024168-2022-11233
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention