MAUDE Adverse Event Report: GYRUS ACMI, INC. 0.035" ANGTIP HYBRID WIRE BX/5; 0.035" HYBRID WIRE, BOX OF 5

Model Number	GWH3505RA
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the 0.035" angled tip, hybrid guidewire had black flakes coming off while inside the patient during use.The issue occurred during an unidentified, diagnostic procedure which was completed with another guidewire.The procedure had to be extended by 10 minutes while the black flakes were retrieved from inside the patient.There were no reports of patient harm or impact due to the delay.Related patient identifier (b)(6).

• Brand Name: 0.035" ANGTIP HYBRID WIRE BX/5
• Common Device Name: 0.035" HYBRID WIRE, BOX OF 5
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• MDR Report Key: 17131795
• Report Number: 2429304-2023-00191
• Device Sequence Number: 6457680
• Product Code: EYA
• UDI-Device Identifier: 00821925031432
• UDI-Public: 00821925031432
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/14/2023
• Report Date (Section F): 05/16/2023

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: GWH3505RA
• Device Lot Number: 91905597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2023
• 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
• Patient Sex: Unknown