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

Catalog Number	1012448-08
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined the reported difficulty removing the stylet and shaft separation appear to be related to operational context.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that before use a 2.75x8mm nc trek rx balloon dilatation catheter (bdc) was being prepped and the stylet could not be removed.The physician attempted to remove the stylet and the balloon catheter separated into two pieces.The device was not used and there was no patient involvement.A new same size nc trek was used to continue the procedure.There was 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: 5984112
• Report Number: 2024168-2016-06483
• Device Sequence Number: 13802238
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: (01)08717648151804(17)180630(10)5070863
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 09/28/2016

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: 06/30/2018
• Device Catalogue Number: 1012448-08
• Device Lot Number: 5070863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1