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

Model Number	RF*GA35153A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: device was not implanted.Explanted date: device was not explanted.The involved device was not returned for evaluation.Therefore, the investigation was based on the provided information and evaluation of the retention sample of the involved product code/lot#.Visual inspection of the retention sample revealed no anomaly including a break in the appearance.Magnifying inspection of the retention sample did not find any anomaly that could lead to a shearing of the guide wire.The outer diameter of the retention sample was measured and confirmed to meet the specifications.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.It is likely that the product was subjected to one-way pulling force; the product was subjected to repetitive bending force at a 90-degree angle; the product kept in a curved shape is subjected to repetitive one-way torque force; or the product was subjected to pulling force in the state of being formed into a loop-like shape.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr 2243441-2019-00101 for the importer report.[mw5089711].
Event or Problem Description
Terumo medical received an fda medwatch report # mw5089711.The event description states: "pt presented to ir for placement of bilateral nephrostomy tubes.During procedure guide wire sheared off and was retained in subq fat around kidney.Provider made pt and wife aware.No further interventions were necessary".

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9208553
• Report Number: 9681834-2019-00177
• Device Sequence Number: 409334
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 04987350773159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 10/31/2021
• Device Model Number: RF*GA35153A
• Device Catalogue Number: GR3506
• Device Lot Number: 190218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/18/2019
• 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: Other