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

Model Number	29420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the microcatheter was fractured.A 135/10 renegade hi-flo kit was selected for use in an embolization of hepatic hemangioma.During the procedure, when the physician unpacked the package and after sufficient flushing was done, it was noted that the microcatheter was fractured when it was removed from the carrier hoop.The device did not enter the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a slight stretching and a fracture of the shaft.The fracture was located 2.5cm from the hub.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the microcatheter was fractured.A 135/10 renegade hi-flo kit was selected for use in an embolization of hepatic hemangioma.During the procedure, when the physician unpacked the package and after sufficient flushing was done, it was noted that the microcatheter was fractured when it was removed from the carrier hoop.The device did not enter the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10359427
• Report Number: 2134265-2020-10305
• Device Sequence Number: 14243672
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 05/10/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0023925355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 55