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

Catalog Number 1012450-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual inspection was performed on the returned device.The shaft separation and kink were confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that a 3.25x15mm nc trek rx balloon dilatation catheter (bdc) was inserted into an unspecified guide catheter and the proximal shaft kinked and then separated outside the anatomy.No resistance was noted during insertion.The device was withdrawn without resistance from the guide catheter.A new same size nc trek was used to continue the procedure.There was no adverse patient effect and no clinically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): 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: 5848179
• MDR Text Key: 51486304
• Report Number: 2024168-2016-05166
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: (01)08717648151934(17)190228(10)60315G1
• 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
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1012450-15
• Device Lot Number: 60315G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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
• Patient Age: 72 YR