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

Model Number	PSC18090A
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product code is dqy for catheter but this code is not populating the information for this 3500a.
Event or Problem Description
The catheter tip fell off during a random sfa procedure.Not overly calcified or tortous.

• Brand Name: CROSSWALK
• Common Device Name: PERIPHERAL SUPPORT CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12303167
• Report Number: 3004718255-2021-00233
• Device Sequence Number: 3670822
• Product Code: DQY
• UDI-Device Identifier: 04547327133494
• UDI-Public: (01)04547327133494(17)240331(10)210406K02A
• 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): 08/09/2021
• Report Date (Section F): 09/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: PSC18090A
• Device Catalogue Number: PSC18090A
• Device Lot Number: 210406K02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2021
• 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: 58 YR
• Patient Weight: 220
• Date Report Sent to FDA: 09/08/2021