MAUDE Adverse Event Report: AV-ASAHI ASAHI SION BLUE PTCA GUIDE WIRE

Catalog Number	AHW14R004S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
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.Date of event - estimated.(b)(4).Evaluation summary: the analysis was performed by asahi intecc.Co.Ltd: the device was returned for analysis.The stretched coils were confirmed.Additionally, a fracture of the proximal segment of the core wire was observed microscopically.The lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
Event or Problem Description
It was reported that an asahi sion blue guide wire was selected for the procedure.Upon removal of the asahi sion blue guide wire from the anatomy, the tip coils were observed to be unraveled (stretched).There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.Returned goods analysis found that the core of the guide wire was separated.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI SION BLUE 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: 7238948
• Report Number: 3003775027-2018-00033
• Device Sequence Number: 10953611
• Product Code: DQX
• UDI-Device Identifier: 04547327086226
• UDI-Public: 04547327086226
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100578
• 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): 01/17/2018

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: 07/31/2020
• Device Catalogue Number: AHW14R004S
• Device Lot Number: 170824A161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1