MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Impulse; catheter, intravascular, diagnostic

Model Number	8160
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in the coronary artery.An impulse catheter-diagnostic was selected for use.During the procedure, upon insertion of the device outside the patient, the catheter seemed to get stuck in a non-boston scientific valve and was fractured.The physician was unable to unscrew the valve and pull out the rest of the catheter, so the catheter was physically cut.The procedure was completed with another of the same device.The patient is stable post procedure.
Additional Manufacturer Narrative
Date of event is estimated based on the aware date as the exact event date was not reported.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: Impulse
• Common Device Name: catheter, intravascular, diagnostic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50882175
• Report Number: 2124215-2026-50858
• Device Sequence Number: 9791849
• Product Code: DQO
• UDI-Device Identifier: 08714729304784
• UDI-Public: (01)08714729304784(17)251004(10)60500194
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 10/04/2025
• Device Model Number: 8160
• Device Catalogue Number: 8160
• Device Lot Number: 0060500194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 10/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Abbott CoPilot? Bleedback Control Valve.
• Patient Sex: Unknown