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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved glidecath was used intra-operative.They were doing a contra lateral retrograde access for a diagnostic angiogram of the lower extremity.They accessed the right and were going up the aortic bifurcation and to the other side.Advancing the wire first, then the catheter, and when the doctor was advancing over the bifurcation the front end detached from the second half.The catheter broke in two pieces and then the doctor had to snare the distal end to remove from the patient body.The patient was fine and was in stable condition.There was no blood loss.There is not a direct allegation.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12041605
• Report Number: 2243441-2021-00024
• Device Sequence Number: 3870625
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/22/2021
• Report Date (Section F): 06/22/2021

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: RF*ZV9410GA
• Device Lot Number: 200609
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 06/22/2021