MAUDE Adverse Event Report: AV-ASAHI ASAHI CONFIANZA PRO PTCA GUIDE WIRE

Catalog Number	82902-02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the analysis was performed by asahi intecc.Co.Ltd: the device was returned and analyzed.The tip separation was confirmed.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the obtained information and investigation outcome, it was presumed that the tip segment of the confianza pro wire was trapped by the target cto lesion when repeated bending force was inadvertently applied by wire manipulation to cross.The force led the core wire to fracture, and the coil wire was elongated and eventually fractured by pulling force applied during withdrawal of the guide wire from the anatomy.The device is manufactured by asahi intecc.Co.Ltd.(b)(4).(b)(4) distributes the device and is responsible for mdr reporting.
Event or Problem Description
It was reported that during a procedure of the chronic, totally occluded posterior tibia vessel, the asahi confianza guide wire was being manipulated when the tip became detached in the occlusion.The device fragment was removed using a snare device without reported issue.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Initial 30-day medical device report was filed without the method codes.

• Brand Name: ASAHI CONFIANZA PRO PTCA GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-ASAHI; asahi intecc co. ltd med div; 3-100 akatsuki-cho; seto 489-0 071; JA 489-0071
• MDR Report Key: 6730686
• Report Number: 3003775027-2017-00125
• Device Sequence Number: 932187
• Product Code: DQX
• UDI-Device Identifier: 04547327058162
• UDI-Public: 04547327058162
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K052339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 82902-02
• Device Lot Number: 160923A041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR