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

Model Number	29417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was broken.A 105/3.0/2.5/.021/20 renegade microcatheter was selected for use.Upon unpacking, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications reported and patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically inspected for damage.The device showed damage in the form of a stretched and fractured shaft located 7.3cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for stretching and a fracture.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the catheter was broken.A 105/3.0/2.5/.021/20 renegade microcatheter was selected for use.Upon unpacking, it was noted that the catheter was broken.The procedure was completed with another of the same device.No complications reported and patient was stable.

• Brand Name: RENEGADE
• 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: 16005181
• Report Number: 2124215-2022-53361
• Device Sequence Number: 5783839
• Product Code: DQO
• UDI-Device Identifier: 08714729375395
• UDI-Public: 08714729375395
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K020012
• 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): 02/07/2023

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: 01/04/2025
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0028807812
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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: 72 YR
• Patient Sex: Female