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

Model Number	80617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A renegade stc 18 infusion catheter was selected for use during a trans-arterial chemo embolization, in the arteries of the liver.During the procedure, it was noted that the renegade stc broke within the base catheter.The physician had to entirely remove the base catheter with the broken renegade stc in it, and the procedure was completed successfully by regaining access with a base catheter and advancing a non-boston scientific microcatheter for the delivery of the embolic beads.There was no harm to the patient.
Event or Problem Description
It was reported that the catheter broke.A renegade stc 18 infusion catheter was selected for use during a trans-arterial chemo embolization, in the arteries of the liver.During the procedure, it was noted that the renegade stc broke within the base catheter.The physician had to entirely remove the base catheter with the broken renegade stc in it, and the procedure was completed successfully by regaining access with a base catheter and advancing a non-boston scientific microcatheter for the delivery of the embolic beads.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product to boston scientific consisted of a renegade stc-18 micro-catheter.The device was inspected for damage or irregularities.The renegade showed multiple bends and kinks on the shaft.The shaft was separated 41.6cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint for shaft damage was confirmed.No other issues were identified during the product analysis.

• Brand Name: RENEGADE STC 18
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12572755
• Report Number: 2134265-2021-12289
• Device Sequence Number: 10993994
• Product Code: DQO
• UDI-Device Identifier: 08714729444466
• UDI-Public: 08714729444466
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0022816507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown