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

Catalog Number 1012453-15

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2016

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 was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 4.0x15 nc trek was removed from the package when it was noted that there was no stylet and there does not appear to be a balloon on the device.This device was not used.Another nc trek was used to complete the procedure without further incident.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the outer member was separated at the proximal balloon seal and the inner member was separated at the proximal balloon marker.The protective sheath and distal end of the device (balloon, tip and inner member with the distal balloon marker) were not returned.It is possible the separation occurred during the removal of 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 regards to the difficulty with removing the protective sheath appears 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.

Event Description

Subsequent to the initial 30-day medical device report, the following information was received: resistance was met removing the protective sheath from the 4.0x15 nc trek balloon dilatation catheter.The nc trek was prepared in normal fashion and the device appeared normal.The nc trek was advanced over the guide wire, but resistance was met.The nc trek had not exited the guide catheter when it was decided to remove it from the guide wire.Another nc trek was used to complete the procedure without further incident.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: 5870367
• MDR Text Key: 51976086
• Report Number: 2024168-2016-05350
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: 09/30/2018
• Device Catalogue Number: 1012453-15
• Device Lot Number: 51013G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• 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
• Patient Sequence Number: 1