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

Model Number 1012455-08

Device Problems Material Rupture (1546); Difficult to Advance (2920)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the proximal right coronary artery (rca) with heavy calcification and moderate tortuosity.The 5.0x8mm nc trek balloon dilatation catheter (bdc) had resistance with the lesion during advancement and ruptured during the first inflation at 12 atmospheres (atms).The bdc was soaked in saline and was prepared (air aspiration) outside the anatomy prior to use.There was no resistance when the protective sheath was removed.There was no resistance during removal.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 15508874
• MDR Text Key: 306285080
• Report Number: 2024168-2022-10141
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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