MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 80617

Device Problems Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported that the guide wire was withdrawn with foreign body.A 130/20/straight/1ro renegade stc-18 microcatheter was used in a transcatheter arterial chemoembolization.During procedure, it was noted that there was resistance upon delivering the guide wire, however the guide wire was withdrawn with foreign body.The procedure was completed with another of the same device.No complications reported and patient was stable.

Event Description

It was reported that the guide wire was withdrawn with foreign body.A 130/20/straight/1ro renegade stc-18 microcatheter was used in a transcatheter arterial chemoembolization.During procedure, it was noted that there was resistance upon delivering the guide wire, however the guide wire was withdrawn with foreign body.The procedure was completed with another of the same device.No complications reported and patient was stable.It was further reported that the found foreign body was like a cotton wool.Also, the guidewire didn't have problems.

• Brand Name: RENEGADE STC 18
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16018302
• MDR Text Key: 307975487
• Report Number: 2124215-2022-53685
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0027816579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG