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	08/28/2017
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 incidents from this lot.The investigation determined the reported difficulties appear 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 additional nc trek is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the heavily calcified, mildly tortuous, mid to proximal right coronary artery.It was reported that the 2.50 x 12 mm nc trek was advanced for pre-dilatation of the lesion; however, resistance was felt during advancement to the lesion.The balloon ruptured on the first inflation at an unspecified pressure, due to the calcification, and was removed from the anatomy without issue.The 2.25 x 12 mm nc trek was advanced for pre-dilatation of the lesion; however, again resistance was felt during advancement to the lesion.The balloon ruptured on the first inflation at an unspecified pressure, due to the calcification and was removed from the anatomy without issue.A smaller nc trek balloon catheter was used successfully for pre-dilatation and a 2.5 x 12 mm xience alpine stent was deployed.No adverse patient effects or clinically significant delay in the procedure were 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: 6850454
• Report Number: 2024168-2017-07342
• Device Sequence Number: 10886461
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: 08717648151699
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012446-12
• Device Lot Number: 70707G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1