MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number	29420
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 31 aug 2023.It was reported that the microcatheter was bent and kinked.The target lesion was located in the moderately tortuous and non-calcified vessel.A 135/20 renegade hi-flo was selected for uterine artery embolization.During the procedure, it was noted that the microcatheter was bent and kinked inside the patient's body.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed a fracture located 18.5cm from the hub.
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 renegade device showed a fracture located 18.5cm from the hub and a kink located 116.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for shaft damage.No other issues were identified during the product analysis.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17799255
• Report Number: 2124215-2023-49227
• Device Sequence Number: 15298732
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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: 06/04/2025
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0029703334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 56 KG