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

Catalog Number	1012445-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 similar incidents from this lot.The investigation determined the reported difficulty appears 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.The other nc trek and trek coronary dilatation catheters are filed under separate medwatch reports.
Event or Problem Description
It was reported that the patient underwent a coronary procedure to treat a target lesion in the heavily calcified diagonal artery.The 2.5 x 20 mm trek dilatation catheter was advanced to the target lesion and was inflated approximately 4 times.On the last inflation, the balloon ruptured at 18 atmospheres (atm).The device was removed without difficulty and a 2.0 x 8 mm nc trek dilatation catheter was then advanced and inflated approximately 4 times.On the last inflation, the balloon ruptured at 18 atm.The device was removed without difficulty and a 2.75 x 8 mm nc trek dilatation catheter was advanced.This device was also inflated approximately 4 times and ruptured on the last inflation at 18 atm.The device was removed without issue.Additional trek dilatation catheters were used and 2 stents were implanted to complete the procedure.There was no adverse patient sequela or a clinically significant delay in procedure reported.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7004125
• Report Number: 2024168-2017-08714
• Device Sequence Number: 10873738
• Product Code: LOX
• UDI-Device Identifier: 08717648151637
• UDI-Public: 08717648151637
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012445-08
• Device Lot Number: 61026G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR