MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

Model Number	M5PIVL7060
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The reported difficulties to remove and subsequent balloon detachment could not be confirmed based on the information available.Per the ifu, it is noted: "do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury." the cause of the device becoming stuck could not be definitively determined.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.
Event or Problem Description
It was reported that a shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used during a procedure to treat the superficial femoral artery (sfa)/popliteal.180 ivl pulses were delivered.During the balloon removal attempt, the balloon would not pass through the sheath and detached from the ivl catheter.The balloon separated inside the patient after excessive force was applied during removal attempts.A second access site was required, and the detached balloon was subsequently retrieved with a snare.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 24223187
• Report Number: 3015053858-2026-00009
• Device Sequence Number: 8205865
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)271031(10)82352167
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K203365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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 Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82352167
• 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: 01/14/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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: SNARE - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown