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); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat an unspecified lesion.It was reported that two hundred and seventy pulses (270) were delivered.During the tenth treatment cycle, the shockwave balloon ruptured and would not deflate.Upon removal attempt, the balloon's sheath became lodged and could not be withdrawn from the 7f introducer.The shaft broke when the surgeon pulled on the shaft to remove the stuck balloon.The physician had to cut the guide catheter to remove the introducer with the balloon still inside, which prolonged the procedure for the patient.The physician replaced the introducer and completed the procedure successfully.No patient harm was reported for the event.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination has not been performed.Evaluation of the subject device is anticipated but has not yet begun.After the device is received and investigation is completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failures of balloon loss of pressure, unable/difficult to remove and catheter detached balloon or catheter component were confirmed.Per the reported information, the balloon ruptured during the procedure.During investigation, a longitudinal balloon rupture, scuff marks, balloon wrinkling, and a bunched distal balloon end were noted on the balloon surface.The cause of balloon loss of pressure could be attributed to patient calcium.The balloon rupture during the procedure prevented the balloon from fully deflating during removal and caused the device to get stuck at the distal end of the sheath.It is possible that the force used to remove the device resulted in detachment and damage to the outer shaft.The cause of the detachment could be attributed to handling during attempt to remove the device.During investigation multiple kinks were noted on the outer shaft along with longitudinal rupture.The cause of the kinks and rupture is unknown, but it could be attributed to handling.Per the product's instructions for use (ifu), it cautions: 1.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.The presence of the stent could have contributed to the inability to remove the device.2.Do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury.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.

• 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: 24565877
• Report Number: 3015053858-2026-00022
• Device Sequence Number: 13120214
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)270831(10)82347391
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 82347391
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: INTRODUCER (REPLACEMENT) - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown