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

Model Number RF*ZV9410GA

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

[uf mw report# (b)(4).Pdf].

Event 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.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10061748
• MDR Text Key: 191132177
• Report Number: 2243441-2020-00025
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 73