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

Catalog Number 1012448-08

Device Problems Break (1069); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2017

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 relevant information.

Event Description

Reportedly, the proximal shaft of a 2.75x8mm nc trek balloon dilatation catheter (bdc) was noticed to be kinked and broken during unpacking.The bdc was not used and the procedure was successfully completed with a new 2.75x8mm nc trek bdc.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported kink was able to be confirmed.The reported shaft break was unable to be confirmed however there was noted inner member separation and noted stretched outer member.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6819246
• MDR Text Key: 83738427
• Report Number: 2024168-2017-06942
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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: 1012448-08
• Device Lot Number: 50812G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• 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