MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	RF*ZV9410GA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
[uf mw report# (b)(4).Pdf].
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "the procedure with this device was an attempt to revascularize the right external iliac artery stenosis.The attempt was thwarted because the intra-luminal catheter broke at the distal tip.It was retrieved from the patient's vasculature in its entirety by transfemoral wire and sheath access.A glidewire was advanced antegrade across the external iliac artery stenosis, across the common femoral and superficial femoral arteries.A 4 french angled glide cath was advanced over the wire and was used to exchange the stiff, angled glidewire for an amplatz wire.While withdrawing the angled glide catheter over the wire the distal end of it broke off, but remained on the amplatz wire." the original intended procedure: ultrasound guided percutaneous access of bilateral common femoral arteries; aortogram with right lower extremity with removal of fracture catheter.".

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10061748
• Report Number: 2243441-2020-00025
• Device Sequence Number: 14331312
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2020
• Report Date (Section F): 05/15/2020

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: 11/30/2021
• Device Model Number: RF*ZV9410GA
• Device Catalogue Number: CG415
• Device Lot Number: 181228
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2020
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 73
• Date Report Sent to FDA: 05/15/2020