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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported detached balloon was confirmed.The cause of the balloon detachment could be attributed to the patient's calcium.Based on the reported event, the physician encountered difficulty advancing the ivl catheter.The physician decided to retract the catheter.However, the distal end of the balloon broke off, but remained attached to the guidewire.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
It was reported that the physician used the shockwave m5plus peripheral lithotripsy intravascular (ivl) catheter to treat a lesion in the iliac region.While attempting to advance the catheter towards the lesion, the physician encountered difficulty.In an attempt to resolve the issue, the physician decided to retract the catheter.However, the distal end of the balloon broke off, but remained attached to the guidewire.The reported break occurred at about 20mm from the tip of the balloon.The rep confirmed that balloon fragment was still on the guidewire, and it did not fall inside the patient.The physician decided to insert a new sheath and opted for contralateral femoral access.Then the guidewire was advanced with the broken balloon still attached to the newly placed sheath.Finally, the physician successfully removed the broken ivl balloon and guidewire from the newly accessed sheath without causing any harm to the patient.

• 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: 17876092
• Report Number: 3015053858-1023-00055
• Device Sequence Number: 19930140
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)241031(10)82266424
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• 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
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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
• Patient Sex: Unknown