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

Catalog Number 1012448-20

Device Problems Detachment Of Device Component (1104); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The additional nc trek devices are being filed under separate medwatch reports.Evaluation summary: visual inspection was performed on the returned device.A separation, a kink and multiple bends throughout the hypotube were noted during return analysis.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the noted shaft separation; however, the noted kink and bends appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Reportedly, there was an issue with three nc trek balloon dilatation catheters; however, there was no information available.No adverse patient effects were reported.No additional information was provided.The return device analysis of the three nc trek catheters found the following: the 3.5x8mm nc trek: the outer member was stretched and torn at the proximal seal.The 3.75x12mm nc trek: the outer member was stretched at the proximal seal.The 2.75x20mm nc trek: the hypotube was separated.

• 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: 6654847
• MDR Text Key: 78137952
• Report Number: 2024168-2017-05201
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: (01)08717648151835(17)181031(10)51102G1
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/20/2017

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: 10/31/2018
• Device Catalogue Number: 1012448-20
• Device Lot Number: 51102G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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