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

Catalog Number 1012450-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

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 is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during device preparation and prior to use, the protective sheath was difficult to remove. After the device was prepared, resistance was met while advancing the device on the guide wire. The device was removed from the wire and a different device was used in the procedure without reported issue. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: the device was returned for analysis and although the protective sheath was not returned, abbott vascular (av) identified stretching near the proximal balloon seal, which is indicative of the reported difficulty removing the protective sheath. The device was successfully advanced over a proxy guide wire. Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device performance with regards to the difficulty with 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: 6048152
• MDR Text Key: 58137065
• Report Number: 2024168-2016-07186
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1012450-15
• Device Lot Number: 51031G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial