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

Catalog Number 1012453-12

Device Problems Inflation Problem (1310); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 as it is likely that inadvertent mishandling and/or applied force resulted in the reported shaft kink thus resulting in the reported inflation issue as the device was attempted to be inflated.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a 75% stenosed, eccentric lesion with no tortuosity and no calcification in the left main coronary artery.A xience alpine was implanted at the lesion.For post-dilatation, the 4.0 x 12 mm nc trek balloon catheter was advanced and crossed the lesion without resistance.However, the shaft became kinked and the balloon could not inflate.The nc trek was changed to a non-abbott balloon catheter to complete the procedure.Reportedly, the physician commented that device handling was as usual, but extra force might have been applied to the nc trek during advancement to the lesion.There was no adverse patient effect and no clinically significant delay in the procedure.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: 6874308
• MDR Text Key: 86621220
• Report Number: 2024168-2017-07560
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• 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
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1012453-12
• Device Lot Number: 70106G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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