MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE TRACK; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while advancing an otw boston scientific coyote balloon which would not cross a lesion, the cook 5 fr x 55 cm hybrid sheath buckled in the aorta.The md tried advancing the balloon without the sheath support, which led to a kink forming in on the glidewire advantage track.014 wire.The balloon was removed, and the md proceeded to try an rx croserio 2 x 200 balloon.The balloon made it over the wire kink and successfully treated the peripheral disease in the anterior tibial artery.While removing the balloon, it wouldn't pull back over the wire kink.This led to the sheath buckling back into the aorta, so the md advanced the sheath while pulling balloon.This increased the kink in the wire and made the balloon unable to be removed.With a repeated effort to pull the balloon out, the balloon shaft broke at the monorail port, which left the balloon on the shaft of the wire and the proximal balloon shaft was removed.The md then decided to do bilateral common femoral artery (cfa) cutdowns to completely remove the wire and distal monorail balloon.These were successfully and entirely removed at this point.Medical or surgical intervention required.Estimated blood loss less than 250cc.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received 29 sept 2023: the guidewire kinked but did not break.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 17928171
• Report Number: 2243441-2023-00033
• Device Sequence Number: 17734489
• Product Code: DQX
• UDI-Device Identifier: 04987350727886
• UDI-Public: 04987350727886
• 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): 10/12/2023
• Report Date (Section F): 10/12/2023

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: GAT1430
• Device Lot Number: 230127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC COYOTE BALLOON; COOK 5FRX55CM HYBRID SHEATH; RX CROSERIO 2X200 BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/12/2023