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

Model Number	M5PIVL4060
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.Based on the investigation observations, the balloon was detached and was not returned with the device.All emitters showed signs of wear consistent with firing.The distal tip immediately distal to the distal marker band was detached and was removed with the balloon; inner member damage was observed between an emitter and the distal marker band.All emitters and marker bands were accounted for, and a kink was noted proximal to the distal marker band.The reported device detachment was confirmed however, the cause of the detachment/difficulty to remove and subsequent embolization could not be definitively determined.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the superficial femoral artery (sfa).It was reported that from a right pedal approach using a 6 fr sheath, the ivl device was advanced over a 300 cm command wire to the common femoral artery (cfa) for repair of an occlusion extending from the sfa to the popliteal artery.A total of 300 pulses were delivered at 4 atm beginning at the cfa and progressing distally toward the popliteal artery.Upon removal of the ivl device, resistance was encountered; the device was withdrawn from the sheath and discarded.Attempts to deliver a 5x200 drug-coated balloon (dcb) would not cross past the popliteal artery.A smaller 3x40 percutaneous transluminal angioplasty balloon (pta) balloon was introduced but also struggled to cross the lesion.The discarded ivl device was observed, and it was noted that the nylon balloon material had stripped from the ivl device.Using a 2x20 coronary balloon, the embolized ivl balloon material was subsequently recovered.No nylon material was observed within the vascular lumen on angiography or intravascular ultrasound (ivus).The physician performed serial ballooning of the occlusion, and the vessel achieved acceptable pressure gradients throughout the leg.The access site was closed with radial pressure dressing.

• 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: 23589716
• Report Number: 3015053858-2025-00140
• Device Sequence Number: 13233025
• Product Code: PPN
• UDI-Device Identifier: 00195451000232
• UDI-Public: (01)00195451000232(17)251130(10)82296827
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: M5PIVL4060
• Device Catalogue Number: M5PIVL4060
• Device Lot Number: 82296827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: COMMAND WIRE - - MFG UNKNOWN; DRUG-COATED BALLOON - - MFG UNKNOWN; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON - MF
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female