MAUDE Adverse Event Report: ASAHI INTECC SUOH 03; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As i know of right now, dr.(b)(6) was using a suoh-03 across an epicardial collateral.I do not know if it was rca to lca or vice-versa.Apparently, as he was advancing a mc (do not know which one), the tip of the suoh broke off into the collateral vessel.He was able to successfully retrieve the tip and they do have the wire.I am waiting on more information to come back from kate muller (ccl manager).

• Brand Name: SUOH 03
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11853030
• Report Number: 3004718255-2021-00219
• Device Sequence Number: 3925034
• Product Code: DQX
• UDI-Device Identifier: 04547327116749
• UDI-Public: (01)04547327116749(17)231031(10)201116A18A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021
• Report Date (Section F): 05/19/2021

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AHW14R013S
• Device Lot Number: 201116A18A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2021
• 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: 05/19/2021