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

Model Number	29417
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a wire pierced through this device.A renegade microcatheter was selected for a prostate artery embolization (pae) procedure.During the procedure, a non-bsc wire pierced the renegade catheter.Another of the same device was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that a wire pierced through this device.A renegade microcatheter was selected for a prostate artery embolization (pae) procedure.During the procedure, a non-bsc wire pierced the renegade catheter.Another of the same device was used to complete the procedure.No patient complications were reported.Returned product consisted of a renegade hi-flo micro-catheter with a.014 guidewire perforating the shaft.The hub, shaft and tip were microscopically examined.The perforation was located 9cm from the tip.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 a wire pierced through this device.A renegade microcatheter was selected for a prostate artery embolization (pae) procedure.During the procedure, a non-bsc wire pierced the renegade catheter.Another of the same device was used to complete the procedure.No patient complications were reported.Returned product consisted of a renegade hi-flo micro-catheter with a.014 guidewire perforating the shaft.The hub, shaft and tip were microscopically examined.The perforation was located 9cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7984756
• Report Number: 2134265-2018-62094
• Device Sequence Number: 1409440
• Product Code: KRA
• UDI-Device Identifier: 08714729235118
• UDI-Public: 08714729235118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973645
• 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,Followup
• Report Date (Section B): 10/31/2018

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: 02/20/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0021900769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GT GUIDEWIRE- TERUMO 16"; GT GUIDEWIRE- TERUMO 16"
• Patient Age: 68 YR