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	09/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.A renegade catheter was selected for use.During removal from the packaging, the catheter surface was hydrated less than 30 seconds prior to removal from the carrier hoop.Resistance was felt during first trial of removal and it was noted that the catheter became separated.The device was never inserted into the patient.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that a catheter break occurred.A renegade catheter was selected for use.During removal from the packaging, the catheter surface was hydrated less than 30 seconds prior to removal from the carrier hoop.Resistance was felt during first trial of removal and it was noted that the catheter became separated.The device was never inserted into the patient.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a stretching and a separation located 4.7cm from the hub.The hub was detached.The shaft was completely separated.The shaft showed multiple small kinks located 70.5cm to 76cm 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: 10627522
• Report Number: 2134265-2020-13670
• Device Sequence Number: 19634637
• Product Code: KRA
• UDI-Device Identifier: 08714729322832
• UDI-Public: 08714729322832
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 07/07/2022
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0024226228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1