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

Catalog Number	1012445-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
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 medical products: guide wire: sion guide cath: heartrail ii 6f 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.
Event or Problem Description
It was reported that the procedure was to treat a non-tortuous, moderately calcified, eccentric and de novo distal left anterior descending artery that was 90% stenosed.During pre-dilatation, a 2.0 x 12 nc trek balloon catheter was inflated once to 6 atmospheres for 10 seconds when it ruptured.The balloon catheter was prepped before use per the instructions for use.There was no resistance met during advancement or removal of the balloon catheter and no other reported issues.A non-abbott balloon was used to complete pre-dilatation.There was no clinically significant delay in procedure and no adverse patient effects.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: 7138956
• Report Number: 2024168-2017-10046
• Device Sequence Number: 1091434
• Product Code: LOX
• UDI-Device Identifier: 08717648151644
• UDI-Public: 08717648151644
• 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): 12/21/2017

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: 11/30/2019
• Device Catalogue Number: 1012445-12
• Device Lot Number: 61208G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1