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

Model Number 1012451-08

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/14/2021

Event Type  malfunction  

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 of the reported lot did not indicate a lot specific quality issue.It was reported that the nc trek bdc was overinflated to 20 atmospheres (atms) on the third inflation.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 moderately tortuous and moderately calcified anatomy resulted in the reported balloon rupture.Additionally, it was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, ifu states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.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 respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous left anterior descending artery (lad).The 3.5x8mm nc trek balloon dilatation catheter (bdc) was attempted to be used; however, the balloon ruptured at 20 atmospheres during the third inflation.Additionally, it was noted the bdc was not soaked prior to use.Another same size non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.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: 12770656
• MDR Text Key: 283685800
• Report Number: 2024168-2021-10086
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151965
• UDI-Public: 08717648151965
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012451-08
• Device Catalogue Number: 1012451-08
• Device Lot Number: 90717G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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