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

Catalog Number 1012448-08

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual and dimensional inspections were performed on the returned device.The shaft separation was confirmed.The difficulty positioning and removing of the device could not be replicated in a testing environment as it was based on operational circumstances.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 difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the heavily calcified, heavily tortuous, proximal circumflex coronary artery.A non-abbott stent was implanted.When advancing a 2.75x08mm nc tek balloon dilatation catheter (bdc), for post dilatation; resistance was felt with the guiding catheter.When removing the bdc from the guiding catheter resistance was felt with the guide catheter and the distal shaft separated in the guide catheter.The distal shaft was removed from the guide catheter by hand and another nc trek bdc was used to complete the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the core failure may be attributed to ductile overload at a bend.The fracture surface revealed dimples, small pits and smearing.The outer and inner surfaces were documented as requested.Surface cracks were observed.There was no damage noted to the bdc prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 7297373
• MDR Text Key: 101132501
• Report Number: 2024168-2018-01386
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: 08717648151804
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1012448-08
• Device Lot Number: 50904G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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