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

Model Number	29417
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device showed multiple kinks and bends.The device also showed stretching and separations located 24.5 and 26.5cm from the hub.The device was not completely separated the inner liner was still attached.The device could not be functionally tested in a guiding catheter due to the damage on the device.Inspection of the remainder of the device revealed no damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 07may2020.It was reported that the device could not cross lesion.The 50% stenosed target lesion was in an acute angled and moderately calcified renal artery.A 105/3.0/2.5/.021/20 renegade was selected for use.During procedure, it was noted that the device could not cross the lesion due to the gap between guidewire and microcatheter.The procedure was completed with a different device.There were no patient complications reported.However, device analysis revealed device separation.

• Brand Name: RENEGADE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10088082
• Report Number: 2134265-2020-06899
• Device Sequence Number: 11403307
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 10/01/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0022877635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR