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

Catalog Number 1012278-12

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

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 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 to treat a target lesion in the proximal left anterior descending artery (lad).The 4.0 x 12 mm trek dilatation catheter was inflated a total of 5 times without issue.The device was deflated fully; however, difficulty was noted during removal.The balloon was bunched at the catheter tip and difficulty was noted removing the device.The guide catheter, guide wire and trek dilatation catheter were removed as a single unit.Final angiography noted no patient injury.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Internal file number - (b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.There was no balloon bunching noted; thus, the reported winged (bunched) balloon could not be confirmed.The reported difficulty removing the device from the guiding catheter 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.A review of the complaint history identified no other similar incidents from this lot.The trek rx coronary dilatation catheter (cdc), instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).Additionally, 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 reported ifu violations did not cause or contribute to the reported event.The investigation determined the reported difficulty removing the device from the guiding catheter appears to be related to circumstances of the procedure.A conclusive cause for the reported winged (bunched) balloon could not be determined.There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, a user facility medwatch report (mw5074981) was received stating: event desc: ptca balloon became stuck when attempting to withdraw the device from the prox lad.Md had to use much more force than necessary to remove.We had to remove the guide catheter, guidewire and balloon, all as one unit from the body.It was then noticed the balloon was bunched up at the tip of the guide, preventing the balloon from being pulled into the guide.F/u angis showed no disruption of the vessel.

• 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
• MDR Report Key: 7287477
• MDR Text Key: 100790184
• Report Number: 2024168-2018-01297
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012278-12
• Device Lot Number: 61007G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR