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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Ethnicity - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- inventory.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the shipping inspection record of the involved product code/lot# combinations were conducted with no findings.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 past findings, it is known that peeling of the outer layer may occur in the following cases.When a guidewire is pulled proximally, or a metal needle is pushed distally while both devices are in the combined state.When a guidewire is used in combination with a metal torque device.Ifu states: do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.Do not use a metal torque device with the glidewire.Use of a metal torque device may result in damage to glidewire.It is likely that the cause of the occurrence was one of the possibilities described above in the investigation results.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the wire was in the body and the doctor noticed the coating was stripping and wire was exposed.It was then pulled out of patient.The blood loss was less than 250cc.The condition of the patient was stable.The procedure was completed by switching the wires.Additional information was received on 05oct2021.The type of procedure performed was a left lower extremity angiogram.The coating did not come off inside the patient.Testing to determine that there was nothing left in the patient was not necessary.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12701959
• Report Number: 9681834-2021-00182
• Device Sequence Number: 1468219
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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
• Patient Age: 66 YR
• Patient Weight: 82