MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA UNK RADIFOCUS; WIRE, GUIDE, CATHETER

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician from the or asked if the glidewires could potentially sheer off and cause a visual curly cue in a patient.The physician stated she was using a terumo glidewire over a year ago and accessing the subclavian for a pacemaker.She suspects that she sheared off part of the glidewire through the long needle in the patient and could see it under fluoroscopy upon reexamination.Additional information was received on 01nov2019.The physician stated they did a pacemaker over one year ago and noticed what looked like a curly bit on a cxr afterwards.It almost looked like a figure of an 8 suture with a knot on the cxr, only about 1.5 cm long.It looks like the position where she sometimes puts a hemostatic stitch to cinch a bit of pectoralis muscle around where the lead exits the pectoralis muscle to meet the generator in the pacemaker pocket.She asked around and the or supervising nurse did not know of a radioopaque suture they use in the or.The suture she usually uses for this hemostatic stitch is vicryl which usually does not show up on a cxr.Three months ago, the patient was taken to surgery for a lead revision by another surgeon who saw this object under fluoroscopy and looked for it during his surgery.However, could not find it in the pacemaker pocket.It was noticed in the operative note that there was difficulty with venous access and had used a terumo glidewire.Sometimes the coating frays a bit (from wire touching the sharp tip of the needle) as the wire goes in and out of the needle if the wire makes a slight bend (right subclavian/svc turn).The patient was reported to be ok.Additional information was received on 04nov2019.The doctor stated that she was not even sure if it is a wire fragment or just a suture.

• Brand Name: UNK RADIFOCUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9362937
• Report Number: 2243441-2019-00111
• Device Sequence Number: 14010797
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2019
• Report Date (Section F): 11/22/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• 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
• Date Report Sent to FDA: 11/22/2019