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

Catalog Number 1012449-08

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2017

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.Concomitant medical products: guide wire: whisper, stent: 3.0x26mm resolute, guide catheter: ar1.The device was not returned for evaluation.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 incidents from this lot.The investigation determined the reported difficulty appears 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.User facility medwatch report mw5074585.

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion in the right coronary artery.A 3.0x8mm nc trek balloon dilatation catheter (bdc) was being inserted for post-dilatation of a non-abbott stent; however, blood was noted at the connection point and it was decided to remove the bdc.The shaft separated inside the guiding catheter while being removed.The entire intervention system was removed as a unit.Using a new guide wire and guide catheter, a non-abbott stent was implanted to successfully complete the procedure with 0% residual stenosis and timi 3 flow.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was 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: 7275069
• MDR Text Key: 100456175
• Report Number: 2024168-2018-01152
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151859
• UDI-Public: 08717648151859
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• 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: 1012449-08
• Device Lot Number: 70822G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 52