MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	80617
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.A 130/20 renegade stc 18 infusion catheter selected for use.Upon unpacking, it was noted that themicrocatheter was fractured.The procedure was completed with another of the same device.No complications reported and patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the hub, tip and inner/outer shaft included microscopic and visual inspection.Inspection revealed a complete separation of the shaft located 41mm from the strain relief.The fracture faces of the device had tensile damage.Analysis of the rest of the device found no other damage or defective.
Event or Problem Description
It was reported that the microcatheter was fractured.A 130/20 renegade stc 18 infusion catheter selected for use.Upon unpacking, it was noted that themicrocatheter was fractured.The procedure was completed with another of the same device.No complications reported and patient was stable.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9458617
• Report Number: 2134265-2019-15533
• Device Sequence Number: 3072638
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 01/28/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023418369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 60