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

Catalog Number 1012272-15

Device Problems Difficult to Remove (1528); Folded (2630); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2014

Event Type  malfunction  

Event Description

It was reported that the patient presented with a st elevated myocardial infarction (stemi) and an occluded distal right coronary artery (rca).A prowaterflex guide wire crossed the distal rca lesion.A 2.5x15mm trek dilatation catheter was advanced to the lesion without resistance.Once at the lesion, the markers did not appear aligned co-axially aligned with the wire.After balloon inflation, the balloon locked with the wire and appeared deformed.The balloon was able to deflate, however it remained stuck and intertwined with the wire.Both were removed a single unit and the procedure was completed using another wire and balloon.There were no adverse patient effects and there was no clinically significant delay.The patient is in reported fine condition.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The reported difficult to remove from the guide wire and unusual appearance was confirmed.The reported mis-aligned balloon markers were not confirmed due to the condition of the returned device.Based on visual, dimensional and analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.The prowaterflex guide wire, referenced is being filed under a separate medwatch mfr number.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4217603
• MDR Text Key: 5078271
• Report Number: 2024168-2014-07141
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/06/2014

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: 06/30/2017
• Device Catalogue Number: 1012272-15
• Device Lot Number: 40731G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Treatment: GUIDE WIRE: PROWATERFLEX
• Patient Age: 65 YR