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
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.This report has been submitted by the importer under this mdr report number 2429304-2023-00190.
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, but there were no reports of patient harm or impact due to the delay.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not returned and a specific root cause of the suggested event could not be identified with the information received.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17131815
• Report Number: 3011050570-2023-00067
• Device Sequence Number: 6458043
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIGID SCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown