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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC,
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16385434
• MDR Text Key: 309654751
• Report Number: 2243441-2023-00004
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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
• Device Operator: 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
• Date Report Sent to FDA: 02/16/2023
• Distributor Facility Aware Date: 01/25/2023
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO AZUR COILS - ITEM 45-751632 ITEM 45-652050.
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female