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

Model Number	1012447-08
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 reported from this lot.It was reported that the nc trek bdc was overinflated to 20 atmospheres (atms).It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, it is likely the combination of the ifu deviation and the mildly tortuous and mildly calcified anatomy resulted in the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to user error/operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified left anterior descending artery.A 2.5x8 mm nc trek balloon was inflated twice to 20 atmospheres and ruptured.Another same size nc trek was used to successfully complete the procedure.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
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12308575
• Report Number: 2024168-2021-07076
• Device Sequence Number: 11683004
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 1012447-08
• Device Catalogue Number: 1012447-08
• Device Lot Number: 01120G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1