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

Model Number	80617
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent splenic artery embolization under local anesthesia.The patient was placed in a lying position, was placed regular disinfecting towel, the right inguinal region was local anesthetized with 5 ml of 2% lidocaine, the right femoral artery was punctured, the 5f vascular sheath was placed through the femoral artery.A.014/190cm gw transend periph and 150/20/straight/1ro renegade stc-18 infusion catheters were delivered to the bifurcation of the iliac artery.The stc microcatheter was disassembled, and the sheath was removed.The microcatheter was flushed with 10 cc of saline in both directions and the microcatheter was removed.The microcatheter was found to be deformed and fractured, and was unable to be used normally, and there was difficulty in advancing the wire inside the catheter, so a new set of stc microcatheter and transend combination was used to complete the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a renegade hi-flo micro-catheter.The hub and shaft were visually inspected.The renegade device showed damage in the form of twist/crushed shaft located 149.5cm and 153.5cm from the hub.There was multiple small bends and kinks located 41cm to 47cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was not confirmed for a break; however, kinks and shaft damage were confirmed.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent splenic artery embolization under local anesthesia.The patient was placed in a lying position, was placed regular disinfecting towel, the right inguinal region was local anesthetized with 5 ml of 2% lidocaine, the right femoral artery was punctured, the 5f vascular sheath was placed through the femoral artery.A.014/190cm gw transend periph and 150/20/straight/1ro renegade stc-18 infusion catheters were delivered to the bifurcation of the iliac artery.The stc microcatheter was disassembled, and the sheath was removed.The microcatheter was flushed with 10 cc of saline in both directions and the microcatheter was removed.The microcatheter was found to be deformed and fractured, and was unable to be used normally, and there was difficulty in advancing the wire inside the catheter, so a new set of stc microcatheter and transend combination was used to complete the procedure.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13552620
• Report Number: 2134265-2022-01175
• Device Sequence Number: 17392929
• Product Code: DQO
• UDI-Device Identifier: 08714729444503
• UDI-Public: 08714729444503
• 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): 03/23/2022

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: 03/08/2024
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0027103129
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 57 KG