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

Model Number	AG141302J
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Proximal and mid rca lesion.Stent was placed in distal lesion.Difficulty getting balloon to post dil over run through.Sent grand slam down for more support, wouldn't advance so they removed and noticed the distal end was "broken".Sent second grad slam down, again removed wire and distal end broken.No patient harm.

• Brand Name: ASAHI INTECC
• Common Device Name: GRAND SLAM
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10141210
• Report Number: 3004718255-2020-00143
• Device Sequence Number: 2561130
• Product Code: DQX
• UDI-Device Identifier: 04547327055871
• UDI-Public: (01)04547327055871(17)221231(10)200107A181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2020
• Report Date (Section F): 06/10/2020

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: 12/31/2022
• Device Model Number: AG141302J
• Device Catalogue Number: AG141302J
• Device Lot Number: 200107A181
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2020
• 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: 06/10/2020