MAUDE Adverse Event Report: RADIFOCUS GLIDEWIRE; WIRE, GUIDE, CATHETER

RADIFOCUS GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GM1831
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during an endoscopy procedure, the guidewire tip broke/sheared off.The patient had to be transferred to another facility as a result.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	RADIFOCUS GLIDEWIRE
Common Device Name	WIRE, GUIDE, CATHETER
MDR Report Key	12730749
Report Number	2243441-2021-00056
Device Sequence Number	14577531
Product Code	DQX
UDI-Device Identifier	04987350711908
UDI-Public	04987350711908
Combination Product (Y/N)	N
Initial Reporter State	MN
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)	11/01/2021
Report Date (Section F)	11/01/2021
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 Expiration Date	02/28/2023
Device Model Number	GM1831
Device Catalogue Number	GM1831
Device Lot Number	210304
Was Device Available for Evaluation?	No
Was the Report Sent to FDA?	Yes
Distributor Facility Aware Date	10/07/2021
Device Age	7 MO
Event Location	Hospital
Date Report to Manufacturer	10/08/2021
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	11/01/2021
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Usage of Device	N
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Other;
Date Report Sent to FDA	11/01/2021