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

Catalog Number	1012453-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 difficulty removing the device appears to be related to operational context.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 performed to treat a lesion in the proximal right coronary artery with no tortuosity and no calcification.A 4.0 x 20 mm nc trek balloon catheter was advanced to the target lesion.The balloon catheter became stuck with the guiding catheter during removal, and therefore both devices were removed as a single unit.Reportedly, the tip of the guiding catheter had a deformed tip and became caught on the balloon during removal.The procedure was successfully completed using an unspecified balance middle weight guide wire and a 4.0 x 15 mm nc trek balloon catheter.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: 7626429
• Report Number: 2024168-2018-04791
• Device Sequence Number: 16619213
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/21/2018

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: 03/31/2021
• Device Catalogue Number: 1012453-20
• Device Lot Number: 80413G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1