MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number 1012449-15

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that while loading the nc trek balloon onto the guide wire the tip of the balloon appeared kinked.The device was not used; there was no patient interaction.A different device was used in the procedure without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed the inner member was separated at the proximal balloon marker; the outer member was intact.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) identified that the proximal seal was stretched and the inner member had a separation at the proximal balloon marker.It is likely that the account perceived the stretched proximal seal/inner member separation as the kink.The analysis of the returned device suggests that the separation may be related to tensile overload when removing the protective sheath.A search of the lot history record for this specific lot indicated no related non-conformance records.Further assessment was performed per operating procedures and av concluded that there is no indication of a product quality issue.The performance of these devices will continue to be monitored.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6153305
• MDR Text Key: 61890590
• Report Number: 2024168-2016-08659
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: (01)08717648151873(17)180731(10)50812G1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1012449-15
• Device Lot Number: 50812G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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