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

Catalog Number 1012449-08

Device Problems Detachment Of Device Component (1104); Kinked (1339); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during insertion through the rotating hemostasis valve (rhv) a slight kink was noted on the trek shaft, but the device continued to be used.During the procedure of the non-tortuous, mildly calcified, right coronary artery (rca), while inflating the balloon at 2-3 atmosphere, contrast leak was seen at the distal shaft area and the device was noted to be separated.A different balloon was inserted and inflated at the shaft pinning the device in the guide catheter.All devices were removed together without issue.The vessel was re-wired and a guide catheter and a different balloon were used to complete the procedure with a good outcome.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: visual and functional inspections were performed on the returned device.The separation and kink were confirmed.The reported leak was unable to be confirmed however the shaft separation was what was likely perceived by the account as the reported leak as the device was separated into two pieces.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.It should be noted that the coronary dilatation catheters, instruction for use states: prior to use examine all equipment carefully for defects.Do not use any defective equipment.The investigation was unable to determine a conclusive cause for the reported kink; however, the shaft separation and subsequent leak appear to be related to user error.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): 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: 5873911
• MDR Text Key: 52059193
• Report Number: 2024168-2016-05407
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1012449-08
• Device Lot Number: 50603G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR