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

Model Number	7.0X60MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m5plus peripheral intravascular lithotripsy (ivl) balloon catheter successfully delivered 120 pulses in the iliac artery.However, after angiogram was performed, it was noted that some distal emboli was observed in the posterior tibial artery.The physician aspirated the emboli using the penumbra's indigo ® aspiration system.It was reported that there was nothing hard in the chamber and most likely the embolization was a thin material.The ivl treatment achieved good results.There was no report of ivl catheter malfunction.It was mentioned that the arteries had ring stripping, a form of intervention many years ago so the intima and media were very fragile.No additional information was provided.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical inc.; therefore no investigation can be performed.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.Shockwave medical 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: 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: 18080499
• Report Number: 3015053858-2023-00062
• Device Sequence Number: 20756387
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)240930(10)A220916B
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 7.0X60MM
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: A220916B
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PENUMBRA'S INDIGO ® ASPIRATION SYSTEM - PENUMBRA
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown