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

Model Number PSC18090A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2021

Event Type  Injury  

Event 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
• Type of Device: CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12316472
• MDR Text Key: 266361730
• Report Number: 3004718255-2021-00235
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327133494
• UDI-Public: (01)04547327133494(17)240430(10)210521K46A
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2021,08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSC18090A
• Device Catalogue Number: PSC18090A
• Device Lot Number: 210521K46A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2021
• Distributor Facility Aware Date: 08/06/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 260