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

Model Number 80617

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that catheter was punctured.A renegade stc 18 was selected for use in a severely calcified vessel.During the procedure, upon insertion of the guidewire, it was noted that the catheter was punctured.The procedure was completed with another of the same device.No patient complications were reported, and the patient was fine post procedure.

Event Description

It was reported that catheter was punctured.A renegade stc 18 was selected for use in a severely calcified vessel.During the procedure, upon insertion of the guidewire, it was noted that the catheter was punctured.The procedure was completed with another of the same device.No patient complications were reported, and the patient was fine post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically inspected for damage.The renegade device showed multiple bends and kinks throughout the catheter shaft.A hole in the catheter shaft was confirmed located 98cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: RENEGADE STC 18
• Type of Device: 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: 18664167
• MDR Text Key: 334815678
• Report Number: 2124215-2024-02769
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444404
• UDI-Public: 08714729444404
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0030597063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male