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

Catalog Number 1012448-15

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 2.75 x 15 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure.Prior to removal of the bdc from the packaging coil, the shaft was observed to be bent (kinked) at the proximal end near the hub.There was no resistance felt during removal of the bdc from the plastic hoop.The bdc was not used in the procedure.A new 2.75 x 15 mm nc trek rx bdc was used to successfully complete the procedure.There was no patient involvement.There was no reported clinically significant delay in the procedure.Return device analysis revealed a proximal shaft separation.Follow-up with the account confirmed that the separation occurred prior to removal of the bdc from the packaging coil.No additional information provided.

Manufacturer Narrative

Internal file number - 335738/1-1.Evaluation summary: the device was returned for evaluation and abbott vascular (av) confirmed the reported kink at the proximal end near the hub.In addition, av identified that the proximal shaft separated, near the hub, and it was confirmed with the account that the separation occurred prior to removal of the balloon dilatation catheter from the packaging coil.A review of the lot history record revealed no manufacturing nonconformities associated with this lot.Further, a review of the complaint handling database found no similar incidents from this lot.Evaluation of the event concluded that a potential product quality issue exists.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• 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: 7119312
• MDR Text Key: 95508839
• Report Number: 2024168-2017-09750
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• 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: 01/02/2018

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: 02/29/2020
• Device Catalogue Number: 1012448-15
• Device Lot Number: 70325G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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