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

Catalog Number 1012449-15

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical devices: guide wire: sion, run through ex floppy, gaia 1.2, guide catheter: 7f launcher al1.0, stent: synergy (2.25 x 38 mm, 2.5 x 38 mm, 3.0 x 16 mm).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 lesion in the proximal right coronary artery.A 3.00 x 15 mm nc trek rx balloon dilatation catheter (bdc) was selected for post dilatation.There were no issues noted during unpacking, inspection and preparation of the bdc.The bdc was advanced to the lesion and was inflated twice to 14 atmospheres and on angiography the proximal balloon marker was observed to be mislocated well into the balloon's working length.The bdc was removed from the anatomy and the proximal marker was confirmed to be located distal to where it should have been.Another 3.00 x 15 mm nc trek rx bdc was used to successfully complete the post dilatation.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported proximal marker alignment issue.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.A review of the complaint handling database found no similar incidents from this lot.Further assessment per site operating procedures was performed and identified a potential product deficiency related to the manufacture of the device.Av determined that there is no indication that this issue impacts a wider population within this lot or that this is a systemic issue.Av will continue to trend the performance of these devices.

• 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 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: 6179454
• MDR Text Key: 62693827
• Report Number: 2024168-2016-08931
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 1012449-15
• Device Lot Number: 50812G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES