MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA 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	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidecath device involved was used to treat a patient with in-stent restenosis of the left superficial femoral artery (sfa).The entire length of the sfa was stented.The 4fr 65 centimeter angled glidecath was used to access the proximal portion of the stent over a 0.035" 260 centimeter glidewire advantage.The glidecath got stuck in a proximal lesion within the stent, and a large portion of the catheter sheared off when it was attempted to be removed.About half of the glidecath was sheared.The segment that sheared off was easily snared and retrieved from the patient.There was no effect to the patient.The outcome of the procedure was successfully completed.There was no patient injury or surgical intervention required.Additional information was received on 01 mar 2022: the patient was in stable condition.All sheared catheter pieces were retrieved from the patient.Hemostasis was achieved by manual compression.There was no blood loss.The catheter was damaged and the catheter was in two pieces when removed.

• 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: 13892843
• Report Number: 2243441-2022-00006
• Device Sequence Number: 12325234
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2022
• Report Date (Section F): 03/24/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 200416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2022
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 260CM 0.035" GLIDEWIRE ADVANTAGE; 4F 11CM CORDIS AVANTI SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 39 KG
• Date Report Sent to FDA: 03/24/2022