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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI INTECC GRAND SLAM; GUIDW WIRE
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ASAHI INTECC GRAND SLAM; GUIDW WIRE Back to Search Results
Model Number AG141002
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 06/08/2023
Type of Reportable Event Malfunction
Event or Problem Description
Grand slam was advanced into the turnpike spiral.It is believed that the grand slam got caught in the calcium and stripped off the spring coil.
 
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Brand Name
GRAND SLAM
Common Device Name
GUIDW WIRE
Manufacturer (Section D)
ASAHI INTECC
3-100 akatsuki-cho
seto, aichi 489-0 071
JA  489-0071
MDR Report Key17211016
Report Number3004718255-2023-00301
Device Sequence Number6249242
Product Code DQX
UDI-Device Identifier04547327055833
UDI-Public(01)04547327055833(17)251231(10)230126A081
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/27/2023
Report Date (Section F) 06/27/2023
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 Date12/31/2025
Device Model NumberAG141002
Device Catalogue NumberAG141002
Device Lot Number230126A081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/08/2023
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer06/27/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/27/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age74 YR
Patient SexFemale
Patient Weight60 KG
Date Report Sent to FDA06/27/2023
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