MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSWALK; CATHETER

Model Number	PSC18090A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
While attempting to bring the crosswalk up from the pedal sheath the tip of the crosswalk got directed into a small branch and the tip got stuck and was left in the small vessel off the left tibial.It was on a v-18 wire at the time.

• Brand Name: CROSSWALK
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12316472
• Report Number: 3004718255-2021-00235
• Device Sequence Number: 11667869
• Product Code: DQY
• UDI-Device Identifier: 04547327133494
• UDI-Public: (01)04547327133494(17)240430(10)210521K46A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/06/2021
• Report Date (Section F): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PSC18090A
• Device Catalogue Number: PSC18090A
• Device Lot Number: 210521K46A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2021
• 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: Other
• Patient Age: 65 YR
• Patient Weight: 260
• Date Report Sent to FDA: 08/12/2021