MAUDE Adverse Event Report: AV-ASAHI ASAHI GRANDSLAM PTCA GUIDE WIRE

Catalog Number	14940-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient and device codes were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The analysis was performed by(b)(4).Investigation of the device could not be conducted as the grand slam guide wire was not returned.Based on the provided information, it was presumed that lubricity between the guide wire and the balloon catheter was temporarily affected by vessel tortuosity or such substance as blood or contrast media that went into the balloon catheter lumen.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.The additional grandslam guide wire referenced and filed under a separate medwatch report number.
Event or Problem Description
It was reported the procedure was performed to treat a lesion in the popliteal vessel with no calcification or tortuosity.The first grandslam guide wire was advanced through an un-specified balloon dilatation catheter (bdc); however, resistance was noted.The guide wire was retracted, but resistance was met with the bdc; therefore, the guide wire and bdc were removed together.Outside the anatomy, the devices were separated successfully.A new grandslam guide wire was used with the same bdc; however, the same issue occurred.The devices were removed and a new grandslam guide wire was used with the same bdc successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ASAHI GRANDSLAM 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: 7127653
• Report Number: 3003775027-2017-00231
• Device Sequence Number: 1145782
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: 04547327055857
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031277
• 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
• Report Date (Section B): 12/18/2017

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: 05/31/2019
• Device Catalogue Number: 14940-01
• Device Lot Number: 160610A411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1