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

Model Number 1012453-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 10/12/2021

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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.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 this was a procedure to treat a heavily calcified, heavily tortuous and 90% proximal right coronary artery.An nc trek rx 4.0x15mm balloon delivery catheter (bdc) was inserted.However, during advancement, resistance was felt with the lesion.The bdc was unable to cross the lesion; therefore, it was removed.It was noted that resistance was felt during removal.The bdc was replaced with a non-abbott device.There were no adverse patient effects and 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
• MDR Report Key: 12752886
• MDR Text Key: 280193553
• Report Number: 2024168-2021-09979
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 01014G1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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