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

Catalog Number	1012450-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
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.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the 3.25x15 mm nc trek was advanced to the mid left anterior descending coronary artery and attempt was made to inflate the nc trek, but it would not inflate.It was noted at that time that the hub of the nc trek was not attached to the proximal segment of the nc trek.The hub was still connected to the inflation device, but the catheter itself was not connected to the hub.No air entered the anatomy.The nc trek was removed from the anatomy and replaced with a new, same size nc trek, which was successfully used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
Additional Manufacturer Narrative
(b)(4).Visual inspection was performed on the returned device.The reported separation was confirmed.The reported inflation issue could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported shaft separation and inflation issue appear 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.

• 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: 7605708
• Report Number: 2024168-2018-04497
• Device Sequence Number: 1242798
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: 08717648151934
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 06/27/2018

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: 02/28/2021
• Device Catalogue Number: 1012450-15
• Device Lot Number: 80309G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR