MAUDE Adverse Event Report: ASAHI INTECC ASAHI GRAND SLAM; GUIDE WIRE

Model Number	AG141002
Health Effect - Clinical Code	Prolapse (2475)
Type of Reportable Event	Malfunction
Event or Problem Description
Grand slam was being introduced to body through a guideliner and became prolapsed in the guideliner but never made it to the vessel.When the physician attempted to pull it back out to open the prolapse, the wire became entangled in the guideliner and subsequently unraveled.
Event or Problem Description
Grand slam was being introduced to body through a guideliner and became prolapsed in the guideliner but never made it to the vessel.When the physician attempted to pull it back out to open the prolapse, the wire became entangled in the guideliner and subsequently unraveled.

• Brand Name: ASAHI GRAND SLAM
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi, ja, 48900 71; JA 4890071
• MDR Report Key: 8800714
• Report Number: 3004718255-2019-00107
• Device Sequence Number: 326747
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)211231(10)190130A071
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019
• Report Date (Section F): 01/17/2020

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: 12/31/2021
• Device Model Number: AG141002
• Device Catalogue Number: AG141002
• Device Lot Number: 190130A071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/17/2020