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	Foreign Body In Patient (2687)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor used the glidecath device involved (cg415) to deliver.035 coils during a type ii endo leak case.The device was placed up the patient's leg of a covered stent graft and into the aneurysm sack.Upon delivery of the device, an.035 azur coil item (45-751632) the doctor noticed that the coil was stuck and unable to advance or withdraw from the catheter.Upon additional effort the coil became detached from the coil wire.Upon further manipulation to try and deliver the coil and with draw the catheter the tip of the catheter, the device involved separated while the back portion came out.The patient was in stable condition and the case was able to proceed; however, a portion of the device was left in the patient.The procedure was able to be completed with a different catheter.There was no patient injury/medical or surgical intervention required.Additional information was received on 27 jan 2023: the approximate size of the catheter tip that was left in the patient was 5 centimeters.No additional intervention was planned to remove the catheter tip.The doctor decided to leave the catheter piece and proceed with coiling the area with a different catheter and additional coils.

• 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: 16385434
• Report Number: 2243441-2023-00004
• Device Sequence Number: 20257456
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2023
• Report Date (Section F): 02/16/2023

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 201116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2023
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• 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: TERUMO AZUR COILS - ITEM 45-751632 ITEM 45-652050.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/16/2023