MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+; SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	7.0X60MM
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Separation (1562); 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	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination could not be 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 prior to shipping.
Event or Problem Description
An m5+ ivl peripheral catheter was being utilized to treat the iliac artery.A balloon loss of pressure was encountered after 90 pulses had been successfully administered.As the physician was withdrawing the ivl catheter, the balloon became detached from the catheter shaft.The detached portion of the ivl catheter was successfully remove via snaring.To date, no patient sequelae has been reported.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported balloon loss of pressure and balloon detachment was confirmed.However, the cause of the reported failures could not be definitively determined.Based on the reported information and investigation observations, it is possible that the balloon loss of pressure would have prevented the balloon from fully deflating and therefore make it more difficult to withdraw through the sheath.Then, the force used to remove the device caused it to detach at the distal end.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.

• Brand Name: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+
• Common Device Name: SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 18331070
• Report Number: 3015053858-2023-00074
• Device Sequence Number: 15152863
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)241031(10)82266424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 10/31/2024
• Device Model Number: 7.0X60MM
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82266424
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 05/05/2025
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/03/2024; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown