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

Model Number 1012447-15

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported hub separation was unable to be confirmed however there was a noted hypotube separation.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 from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during preparation for use resulted in the noted hypotube separation/reported hub separation; thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that an attempt to air aspirate a 2.5x15mm nc trek balloon dilatation catheter (bdc) with a syringe was made; however, it was not possible because air was coming in the syringe.Additionally, the hub separated from the shaft.The procedure was successfully completed with a new 2.5x15mm nc trek bdc and the deployment of an unspecified drug eluting stent.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
• 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: 10335708
• MDR Text Key: 200811384
• Report Number: 2024168-2020-06265
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: 08717648151767
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

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: 10/31/2022
• Device Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 91128G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2019
• 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