MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5PIVL6060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the superficial femoral artery (sfa).All shockwave pulses were used.After the procedure, the physician found that the outer transparent balloon on the catheter detached from the emitter wire and the balloon was stuck on the 6f super-arrow flex sheath.The detachment occurred during the removal of the shockwave catheter after 10 cycles were completed.Detachment was only spotted when an imaging run was done, and the physicians realized that the sheath was slanted on the angiogram.They had to completely remove the sheath in which they found that the balloon was detached and stuck inside the sheath.There was a slight tug of the catheter during removal.There was no balloon rupture or loss of pressure prior to the inability to remove the device.The balloon was fully deflated prior to the removal.There was no reported patient harm, and the patient is well.
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.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.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure, detachment of device or device component, was confirmed.The device was returned in two sections.The first section included part of the outer shaft, the inner member, the tri-port hub and the connector boot plug end.The second section included the other part of the outer shaft, the balloon and the distal tip.The distal marker brand was noted to be missing.The physician confirmed that the angiogram indicated that nothing was left inside the patient.Per the reported information, the detachment of the device occurred while removing the device from the patient.It was also reported that the sheath was noted to be slanted and there was a slight tug of the catheter during removal.It is possible that the balloon was not fully deflated, and the combination of the slanted sheath and excessive force could have resulted in the detachment of the device.However, this cannot be fully confirmed.

• Brand Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (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: 22205484
• Report Number: 3015053838-2025-00073
• Device Sequence Number: 17833858
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)260331(10)07A241119A
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/15/2025

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: 03/31/2026
• Device Model Number: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 07A241119A
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: 6.0 X 60 GUIDE CATHETER: UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male