MAUDE Adverse Event Report: TERUMO CORPORATION SINGLE USE GUIDEWIRE; GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE

Model Number	G-260-2545S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that the single use guidewire broke inside the duct during an endoscopic retrograde cholangiopancreatography.A nurse reported that "something was different" on the screen and it appeared that the device fragmented.The physician did not try to retrieve the guidewire as it was more of a risk to try to get into the lumen successfully.The device fragment appeared to be about an inch as confirmed through x-ray.The proceduralist needed to abort the procedure after and the patient was transferred to an intensive care unit (icu).Additional information has been requested but no further information was obtained at this time.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): TERUMO CORPORATION; 44-1, 2-chome, hatagaya; shibuya-ku, tokyo-to 151-0 072; JA 151-0072
• MDR Report Key: 17392964
• Report Number: 2429304-2023-00244
• Device Sequence Number: 15162070
• Product Code: OCY
• UDI-Device Identifier: 04953170358234
• UDI-Public: 04953170358234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2023
• Report Date (Section F): 08/05/2022

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: G-260-2545S
• Device Lot Number: 1YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• 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: Hospitalization; Other
• Patient Sex: Unknown