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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the glidecath involved broke off during a case.The broken piece was able to be retrieved and removed.The patient was unharmed and was in stable condition.The outcome of the procedure was positive.The event occurred intra-operative.Additional information was received on 01 mar 2022: the procedure performed was a common iliac angioplasty.The event occurred after a very challenging crossing of bulky plaque.There was an abundance of force and friction involved, and the catheter was in a waltman loop (bent back on itself).The catheter broke about ten centimeters back from the tip.When the catheter was removed, the tip stayed in the aorta.A snare was used to remove the broken piece within one minute, and there was zero harm done.There was no blood loss.The broken tip was removed in its entirety as a single piece.

• 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: 13825354
• Report Number: 2243441-2022-00005
• Device Sequence Number: 2082672
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/18/2022
• Report Date (Section F): 03/18/2022

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CG416
• Device Lot Number: 200902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 03/18/2022