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

Catalog Number	1012446-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2016
Type of Reportable Event	Malfunction
Additional 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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to calcification in the anatomy.The additional nc trek device is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosis located in the distal left circumflex (lcx) artery with heavy tortuosity and heavy calcification.Resistance was felt during advancement of the 2.0 x 12 mm nc trek balloon dilatation catheter (bdc) through the lesion; however, it was able to cross successfully.The balloon ruptured during the first inflation at 10 atmospheres held for 5 seconds.A 2.25 x 12 mm nc trek bdc was used and met with resistance as it was advanced to the lesion.This nc trek balloon also ruptured during the first inflation at 13 atmospheres held for 5 seconds.The stenosis at the lesion was decreased to 50% after the use of the replacement bdc and no additional treatment was performed.There were no adverse patient effects or clinically significant delay in the 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: 6012349
• Report Number: 2024168-2016-06777
• Device Sequence Number: 1420087
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: (01)08717648151699(17)171231(10)50120G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2016

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: 12/31/2017
• Device Catalogue Number: 1012446-12
• Device Lot Number: 50120G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SION, GRANDSLAM