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

Catalog Number 1012276-15

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 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: guide cath: medtronic jr4 6french; 6french guide catheter extension.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient underwent a coronary procedure using a 3.5 x 15 mm trek dilatation catheter and a guide catheter extension.The dilatation catheter balloon was inflated without issue and was deflated.Some resistance was noted during removal and it was thought that the balloon may not have fully deflated.The dilatation catheter moved freely on the guide wire for a bit and then became completely stuck.Per physician, the site the dilatation catheter became stuck was possibly at the site where the guide catheter extension was located.Force was applied, in an attempt to remove the trek and when it was removed, it was noted to be deformed, such that the physician thought that the balloon had sheared in half within the guide catheter.The guide wire, guide catheter extension and guide catheter were removed as a single unit to ensure that no balloon fragments remained in the patient anatomy.The trek balloon was inspected after removal and it did not appear that the balloon ruptured, but instead, seemed to have come off its markers and folded in on itself.There was no clinically significant delay and no adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device and it was noted that the outer member separated at the proximal seal.The balloon was separated from the proximal seal and pulled in on itself at the distal seal; thus, the folded/unusual appearance was confirmed.The deflation issue 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 identified no other similar incidents from this lot.It should be noted coronary dilatation catheters (cdc), trek rx instructions for use, states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/ or damage/ separation of the catheter.The investigation was unable to determine a conclusive cause for the deflation issue; however, the difficulty to remove and folded/unusual appearance appear to be related to circumstances of the procedure.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: 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: 5466638
• MDR Text Key: 39418875
• Report Number: 2024168-2016-01175
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/17/2016

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: 07/31/2018
• Device Catalogue Number: 1012276-15
• Device Lot Number: 50805G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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