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

Catalog Number	1012449-25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
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.Evaluation summary: visual and dimensional analysis was performed on the returned device.The reported separation was confirmed; however, the reported failure to advance could not be replicated in a testing environment as it is based on operational circumstances.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to the patients anatomical conditions and 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 3.0x25 nc trek was being advanced around a bend in the heavily calcified, heavily tortuous diagonal coronary artery for post dilatation of a xience when the middle of the shaft separated.The separated shaft was removed manually and another nc trek was used to 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: 6358642
• Report Number: 2024168-2017-01530
• Device Sequence Number: 18841426
• Product Code: LOX
• UDI-Device Identifier: 08717648151897
• UDI-Public: (01)08717648151897(17)190731(10)60805G1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/24/2017

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: 07/31/2019
• Device Catalogue Number: 1012449-25
• Device Lot Number: 60805G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1