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

Catalog Number	1012452-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
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, dimensional and functional inspections were performed on the returned device.The reported separation was confirmed; however, the difficulty to position of the guide wire could not be confirmed.In this case, a conclusive cause for the reported difficulty could not be determined as the reported complaint could not be confirmed during return analysis.Additionally, it was reported that the shaft separated due to the attempts to load the device onto the guide wire against resistance.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 was unable to determine a conclusive cause for the reported difficulty to position of the guide wire; however, the shaft separation 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 3.75x15mm nc trek balloon dilatation catheter (bdc) could not be advanced over a non-abbott guide wire.When trying to load the bdc on the guide wire and into the guide catheter the hypotube separated.Thus, the nc trek bdc could not be used for post-dilatation.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay.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: 6252013
• Report Number: 2024168-2017-00457
• Device Sequence Number: 10886783
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: (01)08717648152030(17)190430(10)60505G1
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/13/2017

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: 04/30/2019
• Device Catalogue Number: 1012452-15
• Device Lot Number: 60505G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 65