MAUDE Adverse Event Report: ASAHI INTECC ASAHI GRAND SLAM

Model Number	AG141002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mildly tortuous and non-calcified lesion in the left anterior descending artery.A non-abbott guide wire was retracted after an unspecified stent was deployed.Although there was no resistance during removal, the radiopaque portion of the guide wire became detached.It is unknown why the guide wire detached.The detached portion of the guide wire was located outside the unspecified stent.A 190 cm balance middle weight (bmw) universal ii guide wire was advanced to retrieve the separated non-abbott guide wire.The physician intentionally caused the bmw guide wire to become entangled with the detached non-abbott guide wire.Both guide wires were pulled back together through the previously deployed unspecified stent; however, the guide wires became stuck inside the unspecified stent.The distal portion of the bmw guide wire became detached.A second unspecified stent was deployed to crush both detached guide wires against the vessel.The procedure ended at this point.The patient is stable.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.No damage to the previously deployed stent.No resistance during advancement.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mildly tortuous and non-calcified lesion in the left anterior descending artery.A non-abbott guide wire was retracted after an unspecified stent was deployed.Although there was no resistance during removal, the radiopaque portion of the guide wire became detached.It is unknown why the guide wire detached.The detached portion of the guide wire was located outside the unspecified stent.A 190 cm balance middle weight (bmw) universal ii guide wire was advanced to retrieve the separated non-abbott guide wire.The physician intentionally caused the bmw guide wire to become entangled with the detached non-abbott guide wire.Both guide wires were pulled back together through the previously deployed unspecified stent; however, the guide wires became stuck inside the unspecified stent.The distal portion of the bmw guide wire became detached.A second unspecified stent was deployed to crush both detached guide wires against the vessel.The procedure ended at this point.The patient is stable.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.No damage to the previously deployed stent.No resistance during advancement.

• Brand Name: ASAHI GRAND SLAM
• Common Device Name: GRAND SLAM
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi, ja, 489-0 071; JA 489-0071
• MDR Report Key: 8807897
• Report Number: 3004718255-2019-00108
• Device Sequence Number: 18914045
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)210531(10)180615A111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/11/2019
• Report Date (Section F): 01/13/2020

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 Model Number: AG141002
• Device Catalogue Number: AG141002
• Device Lot Number: 180615A111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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
• Date Report Sent to FDA: 01/13/2020