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

Model Number 1012451-20

Device Problems Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified right coronary artery that is 90% stenosed.The 3.5x20mm nc trek balloon dilatation catheter (bdc) had some resistance when removing the protective sheath.Resistance was met with anatomy during advancement and once at the lesion the bdc ruptured during the first inflation at 20 atmospheres.During removal resistance was felt with anatomy.Another unspecified device was used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.No additional information wasp provided.

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 from this lot.It was reported by the account that during inflation, the bdc was overinflated to 20 atmospheres (atms) and the balloon ruptured.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 device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.A conclusive cause for the reported difficulty removing the protective sheath could not be determined; however, the reported balloon rupture, difficulty advancing and removing the device from the anatomy 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.

• 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: 15222646
• MDR Text Key: 304907519
• Report Number: 2024168-2022-08738
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• 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: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 10826G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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