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

Model Number	80617
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating of renegade was fractured.The target lesion was located in the liver.A renegade stc 18 catheter-infusion was selected for use.During preparation, it was noted that the coating of renegade was fractured.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the coating of renegade was fractured.The target lesion was located in the liver.A renegade stc 18 catheter-infusion was selected for use.During preparation, it was noted that the coating of renegade was fractured.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was inspected for any damage or irregularities.The renegade stc 18 was received in the shipping hoop.The hoop was hydrated, and the device was removed.No fractures or damage to the coating was visible to the eye or with the microscope.Tactile analysis could find no places where there was a problem with the coating.It was found to be slippery where it should be when hydrated.An in house guide wire was inserted and the renegade stc 18 was advanced through an in house terumo guide catheter without resistance.No other issues were identified during the product analysis.The reported issue was not confirmed.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14592571
• Report Number: 2134265-2022-06016
• Device Sequence Number: 5517185
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 07/24/2024
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0027895079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG