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

Catalog Number 1012449-20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

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 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 right coronary artery.A 3.00 x 20 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure.There were no issues or leaks noted during prep (air aspiration) prior to use.During advancement of the bdc through the guide catheter, the physician attempted to put negative pressure on the balloon with the unspecified inflation device when he noticed that the plunger of the inflation device came back freely (no suction).The physician then noticed that the hub of the bdc had separated from the proximal shaft of the bdc.The bdc was removed from the anatomy and a new unspecified bdc was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Internal file number -(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub.Av reviewed the lot history record and there were 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 reported from this lot.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being addressed per internal operating procedures.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: 7289912
• MDR Text Key: 100915739
• Report Number: 2024168-2018-01311
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151880
• UDI-Public: 08717648151880
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110134
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012449-20
• Device Lot Number: 70816G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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