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

Catalog Number 1012453-12

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed on the returned device.The reported winged balloon and difficulty removing the device from the guiding catheter were confirmed.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 operational context.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 during a coronary procedure, post dilatation was performed using the nc trek, with two inflations, first to 12 atmospheres (atm) and the second time to 16 atm.The device was pulled back to remove; however, resistance was noted with the guide catheter and the nc trek balloon was noted to be winged.The balloon was inflated two more times, in an attempt to get a better fold for removal; however, the dilatation catheter could not be removed.The nc trek and guide catheter were removed as a single unit.There was no reported adverse patient effect or a clinically significant delay.No additional information provided.

• 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: 7097235
• MDR Text Key: 94986487
• Report Number: 2024168-2017-09499
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• 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
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1012453-12
• Device Lot Number: 70822G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• 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
• Patient Age: 49 YR