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

Model Number	80617
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that markerband malposition occurred.A renegade stc 18 was selected for use in a gastric arterial hemorrhage.During the procedure, it was noted that the mark point of the microcatheter imaging was located nearly 1 cm away from the tip of the microcatheter.Thus, the coil could not be released.The procedure was completed with another of same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that markerband malposition occurred.A renegade stc 18 was selected for use in a gastric arterial hemorrhage.During the procedure, it was noted that the mark point of the microcatheter imaging was located nearly 1 cm away from the tip of the microcatheter.Thus, the coil could not be released.The procedure was completed with another of same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device was returned for evaluation.Inspection of the device revealed an elongated tip section past the marker band with an overall length of 136.75 cm.Microscope inspection of the device revealed the tip section elongated 1.25 cm past the marker band.The hub to the marker band measured 135.5 cm.Xray inspection of the device revealed incorrect marker band spacing.A test/control device was used to verify the incorrect marker band spacing with a side-by-side comparison.No other issues were identified with the device and no patient complications were reported.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19556844
• Report Number: 2124215-2024-32002
• Device Sequence Number: 15131269
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 09/06/2026
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0032375862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 59 KG