MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GRAND SLAM; GUIDE WIRE

Model Number	AG141002
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Grand slam wire at (b)(6) ccl case with dr.(b)(6) had to retrieve the grand slam wire @ it broke off in patient.Vein calcified 80% started with a bmw wire and changed out to the grand slam for easier placement.While advancing grand slam wire, the wire broke off about at the midway portion of the wire.Both portions of the wire were removed.The broken wire had to be snared and removed.

• Brand Name: GRAND SLAM
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12140439
• Report Number: 3004718255-2021-00230
• Device Sequence Number: 17197365
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)240229(10)210312A271
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021
• Report Date (Section F): 07/08/2021

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: 02/29/2024
• Device Model Number: AG141002
• Device Catalogue Number: AG141002
• Device Lot Number: 210312A271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/06/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2021
• 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: 70 YR
• Date Report Sent to FDA: 07/08/2021