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

Model Number N/A

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  Injury  

Event 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.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 13825354
• MDR Text Key: 289224494
• Report Number: 2243441-2022-00005
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 03/18/2022
• Distributor Facility Aware Date: 02/22/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention