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

Catalog Number 1012448-20

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

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 evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the nc trek met resistance in the guide catheter when it was advanced approximately one third into the guide catheter. Multiple wires were in the guide catheter. The nc trek was removed from the guide catheter before it had exited the distal end of the guide catheter. Upon removal, the distal shaft was noted to have separated on the nc trek. Another nc trek was used to complete the procedure with the same guide catheter and other devices. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Correction: the device was initially reported as returning, but has now been reported as not returning because it was discarded at the account. The device was not returned for analysis. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. 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.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6080672
• MDR Text Key: 59512932
• Report Number: 2024168-2016-07625
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1012448-20
• Device Lot Number: 5072161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial