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

Model Number	29420
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that the device got separated when taken out.The 50% stenosed target lesion was located in the mildly tortuous and none calcified renal artery.A 105/20 renegade hi-flo was selected for use.During preparation, the box was opened and the device was attempted to be pulled out by opening the vinyl.It was noted that it felt like the loop (protective tube) and the device were adhered to each other.The device ultimately separated when taken out of the package and was not used.The procedure was successfully completed using another of the same device.There was no effect to the patient.
Event or Problem Description
It was reported that the device got separated when taken out.The 50% stenosed target lesion was located in the mildly tortuous and none calcified renal artery.A 105/20 renegade hi-flo was selected for use.During preparation, the box was opened and the device was attempted to be pulled out by opening the vinyl.It was noted that it felt like the loop (protective tube) and the device were adhered to each other.The device ultimately separated when taken out of the package and was not used.The procedure was successfully completed using another of the same device.There was no effect to the patient.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The device was partially in the shipping tube when returned.The device showed damage in the form of stretching and a fracture located 6.5cm from the hub.The shipping hoop was hydrated, and the device was removed.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.The device was confirmed for shaft stretching and fractures.

• 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: 12485839
• Report Number: 2134265-2021-11693
• Device Sequence Number: 19681134
• Product Code: KRA
• UDI-Device Identifier: 08714729280606
• UDI-Public: 08714729280606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 09/23/2023
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0026237541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1