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

Catalog Number 1012455-08

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mildly tortuous mid right coronary artery.A 5.0 x 8 mm nc trek balloon catheter was advanced to the lesion for post-dilatation and inflated to 16 atmospheres; however, the balloon did not refold properly and during removal of the catheter, the balloon caught on the end of the guiding catheter and could not be removed.Several inflations and deflations were made in an attempt to get the balloon into the guiding catheter but it could not be pulled into the guide and the proximal shaft separated at the hub.The devices were removed as a single unit and the balloon was wrinkled and bunched.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: NC 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: 4505110
• MDR Text Key: 5536446
• Report Number: 2024168-2015-00728
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• 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: 02/04/2015

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: 09/30/2015
• Device Catalogue Number: 1012455-08
• Device Lot Number: 31017G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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