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

Catalog Number 1012449-15

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The 3.0x12 nc trek rx referenced is filed under a separate medwatch report number.

Event Description

It was reported that during preparation of a 3.00 x 15 mm nc trek rx balloon dilatation catheter (bdc) resistance was felt while attempting to remove the protective sheath from the balloon, force was applied and the sheath finally came off of the balloon.Due to the difficulty removing the protective sheath, the bdc was not used in the procedure.An attempt was made to inflate the balloon outside the anatomy and a balloon rupture was confirmed by contrast coming out of the balloon.A 3.00 x 12 mm nc trek rx bdc was then selected and resistance was felt while attempting to remove the protective sheath from the balloon on this bdc also.Force was applied and the sheath finally did come off of the balloon.Due to the difficulty removing the protective sheath, the bdc was not used in the procedure.There was no prep done to either of the balloon dilatation catheters prior to attempting to remove the protective sheath.There was no patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis; however, abbott vascular could not confirm the reported difficult to remove sheath as the sheath was not returned.The outer member was stretched at the proximal balloon seal.The reported balloon rupture could not be confirmed, however, an inner member separation was observed.In this case, it is possible the reported resistance removing the sheath contributed to the reported rupture (noted separation) and noted stretched outer member.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device's performance with regards to the difficulty with removing the protective sheath appears to be related to normal variation found in manufacturing.There was no indication of a product quality issue.The performance of these devices will continue to be monitored.

• 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: 6212907
• MDR Text Key: 63805606
• Report Number: 2024168-2016-09327
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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: 50803G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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