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

Catalog Number	1012447-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: sion blue, guide cath: hyperion jl4.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 of the reported lot did not indicate a lot specific quality issue.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 mini trek and trek rx devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, concentric and heavily calcified left anterior descending (lad) artery that was 99% stenosed.Pre-dilatation at the mid lad was performed with a 1.2 x 6 mm mini trek balloon dilatation catheter (bdc).The first inflation was done at 10 atmospheres (atms), the second at 12 atms; however, the balloon ruptured during the third inflation at 12 atms.Therefore, a 2.5 x 15 mm trek bdc was used in the proximal lad and was inflated at 12 atms; however, the balloon ruptured during the second inflation at 14 atms.A 2.5 x 8 mm nc trek bdc was then used and inflated at 16 atms; however, the balloon ruptured at 18 atms during the second inflation.The devices did not meet any resistance with the anatomy during advancement.The 2.5 x 8 mm nc trek bdc was then replaced with a non-abbott bdc and a xience sierra stent was implanted to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 7531915
• Report Number: 2024168-2018-03773
• Device Sequence Number: 217418
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: 04/30/2020
• Device Catalogue Number: 1012447-08
• Device Lot Number: 70527G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1