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

Model Number	29417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A renegade catheter was selected for a prostatic artery embolization (pae) procedure.The patient had very difficult anatomy; it was very angulated and stenosed.During the procedure, after an attempt of a dyna ct over the high pressure syringe, an overview series was made.While injecting, 3 ml of contrast was injected with a 3ml syringe from hand.When the wire went through the catheter, the catheter split.When the catheter was pulled out, it was noted to be split into two parts.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter broke.A renegade catheter was selected for a prostatic artery embolization (pae) procedure.The patient had very difficult anatomy; it was very angulated and stenosed.During the procedure, after an attempt of a dyna ct over the high pressure syringe, an overview series was made.While injecting, 3 ml of contrast was injected with a 3ml syringe from hand.When the wire went through the catheter, the catheter split.When the catheter was pulled out, it was noted to be split into two parts.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade fiber braided micro-catheter with a guidewire in the device.The device was analyzed as received.The device showed no kinks on the shaft.The device showed damage in the form of the guidewire perforating the side of the catheter shaft.The perforation was approximately 11cm from the tip.The shaft wall was perforated by the guidewire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was not confirmed for a split or break.An image of the complaint device was also returned and reviewed.The image is difficult to analyze due to the angle and the quality of the image.It does show that the guidewire is protruding from the shaft of the catheter.

• 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: 8428100
• Report Number: 2134265-2019-02196
• Device Sequence Number: 239919
• 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): 03/26/2019

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: 04/08/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0022094172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1