MAUDE Adverse Event Report: 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.
Additional Manufacturer Narrative
Implanted date - device not implanted.Explanted date - device not explanted.The actual device was not returned, therefore the analysis of the actual sample could not be performed, as it was not returned to ashitaka factory.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# combination confirmed there was no anomaly in them.Review of the complaint file found no other similar report with the involved product/lot# combination from other facilities.Based on our past knowledge, we are aware that the guide wire may fracture when the following force is applied.When fractured due to repeated bending force of 90°.There was no tapering on the side surface of wire at the fractured section, and a dimple pattern (a hole-shaped pattern) was observed on the fracture surface.When fractured due to continuous torque force in the same direction in a curved state.There was no tapering on the side surface of wire at the fractured section, and a radial pattern was observed on the fracture surface.When fractured due to pulling force.There was a tapering on the side surface of wire at the fractured section.When fractured due to pulling force in a looped state.There were a tapering and a curve on the side surface of wire at the fractured section.A review of the manufacturing record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the[?]guide wire m and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." based on the investigation result, no anomaly was found in the records.It was likely that the fracture occurred due to the application of any of the force described above.From the available information, since the actual product was not returned and investigation could not be performed, the cause of occurrence could not be identified.Please see mdr 2243441-2021-00056 for the importer report.(b)(4).

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12730649
• Report Number: 9681834-2021-00186
• Device Sequence Number: 13822950
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: 04987350711908
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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 Expiration Date: 02/28/2023
• Device Model Number: GM1831
• Device Catalogue Number: GM1831
• Device Lot Number: 210304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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
• Outcome Attributed to Adverse Event: Other