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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION SINGLE USE GUIDEWIRE; GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE
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TERUMO CORPORATION SINGLE USE GUIDEWIRE; GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE Back to Search Results
Model Number G-260-2545S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2022
Event Type  Injury  
Event 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.
 
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Brand Name
SINGLE USE GUIDEWIRE
Type of Device
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 Key17392964
MDR Text Key319829114
Report Number2429304-2023-00244
Device Sequence Number1
Product Code OCY
UDI-Device Identifier04953170358234
UDI-Public04953170358234
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/05/2022,07/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG-260-2545S
Device Lot Number1YK
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/05/2022
Event Location Hospital
Date Report to Manufacturer08/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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