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

Model Number 29420

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10359427
• MDR Text Key: 201528987
• Report Number: 2134265-2020-10305
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• Combination Product (y/n): N
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 55