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

Catalog Number 1012448-08

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of occurrence is estimated.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 the 2.75 x 8 mm nc trek dilatation was noted to be kinked.There was no adverse patient effect reported and no clinically significant delay.No additional information was provided.Returned device analysis noted that the inner member was separated at the proximal balloon marker, but the outer member remained intact.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular 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 stretching/separation may be related to tensile overload when removing the protective sheath.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the devices performance with regard to the difficulty removing the protective sheath appear to be related to normal variation found in manufacturing.There was 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: 6368500
• MDR Text Key: 69018932
• Report Number: 2024168-2017-01666
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: (01)08717648151804(17)180331(10)50416G1
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012448-08
• Device Lot Number: 50416G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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