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

Catalog Number 1012270-15

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528); Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

(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 the procedure was to treat a chronic totally occluded lesion in the distal right coronary artery (rca).A non-abbott non-compliant (nc) balloon was used to post-dilate an implanted stent at the bifurcation area and a 2.0x15mm mini trek balloon dilatation catheter (bdc) was used to be used to open up the side branch.There was reported resistance during advancement of the bdc with the guide catheter and the anatomy.After inflation at the ostium, twice at nominal pressure, the mini trek bdc was kept in position to re-insert the nc balloon for kissing balloon technique to complete the procedure.During advancement of the nc balloon resistance was met with the guiding catheter and a mixture of blood and contrast was noted in the indeflator.It was suspected that the mini trek balloon had ruptured.During the attempt to remove the mini trek bdc resistance with the guiding catheter was felt.The shaft broke during removal and became stuck inside the rca.Angiography was performed at the edge of the guiding catheter.The nc balloon was re-advanced to trap the separated shaft, but the balloon ruptured.A new nc balloon was inserted and the mini trek bdc was removed by trapping it inside the guiding catheter and snaring it out.All part of the mini trek bdc were successfully removed.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported separation was confirmed.The reported balloon rupture was not confirmed; however, a tear was identified in the guide wire notch and is likely what was perceived as the rupture by the account.The reported physical resistance and difficulty positioning and removing the device from the guiding catheter could not be replicated in a testing environment as it was based on operational circumstances.It should be noted coronary dilatation catheters, mini trek rx, global, instruction for use, states: if resistance is felt, determine the cause before proceeding.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.The investigation determined the reported balloon rupture, physical resistance, difficulty positioning and removing the device from the guiding catheter, patient effect and additional treatment appear to be related to circumstances of the procedure.The reported shaft separation appears to be related to user error/circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: MINI 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: 6612878
• MDR Text Key: 76710206
• Report Number: 2024168-2017-04787
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1012270-15
• Device Lot Number: 70221G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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