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

Catalog Number 1012272-15

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2016

Event Type  malfunction  

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 additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified circumflex artery.A 2.5 x 15 mm trek balloon catheter was advanced to the lesion and pre-dilatation was performed.The device was removed without resistance.Angiography was performed and the pre-dilatation was not sufficient so the same trek catheter was again advanced to the lesion without resistance.The balloon was inflated over rated burst pressure (pressure unknown) when the balloon ruptured.While removing the balloon from the anatomy, when pulled into the guiding catheter, the balloon material folded over on itself and got stuck in the guiding catheter.The balloon catheter, guiding catheter and guide wire were removed as a single unit.The lesion was rewired and a new guiding catheter and balloon catheter were advanced.Pre-dilatation was performed and a stent was implanted to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).Visual and functional inspections were performed on the returned device.The balloon rupture and balloon separation were confirmed.The folded balloon and difficulty to remove could not be replicated in a testing environment due to the condition of the returned device.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 trek rx global instructions for use states: balloon pressure should not exceed the rated burst pressure.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.The investigation determined the reported balloon rupture appears to be related to user error.The difficulty to remove and folded appearance appears to be related to circumstances of the procedure.

• Brand Name: 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: 5743629
• MDR Text Key: 48048739
• Report Number: 2024168-2016-04081
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• 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: 07/13/2016

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: 08/31/2017
• Device Catalogue Number: 1012272-15
• Device Lot Number: 50928G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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