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

Model Number	M5IVL4560
Medical Device Problem Codes	Nonstandard Device (1420); Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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 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.
Event or Problem Description
Shockwave medical received a report involving a shockwave m5 peripheral intravascular lithotripsy (ivl) catheter.It was reported that during a procedure in the operating room (or), a catheter was removed from its sealed packaging.Upon opening the carton, it was discovered that the catheter pouch had labels marked "not for human use" and "test sample," and the catheter had a "rejected" label attached.It was reported that blood was observed on the packaging which was later confirmed to be from the physician.Additionally, it was noted that the catheter did not come into contact with the patient, and the ivl treatment was not used to complete the procedure.The method used to complete the procedure remains unknown.Shockwave medical will continue to follow up on the expected return of the device to aid in the investigation efforts.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the packaging issue could not be definitively determined based on the information available.
Additional Manufacturer Narrative
The device was received at shockwave medical, and a visual inspection confirmed the presence of the reject label on the catheter.A comprehensive investigation was completed using information provided by the customer, device history record review, and evaluation of manufacturing controls.The investigation determined the event resulted from an inadvertent packaging/labeling mix-up, where a test/sample unit not intended for human use was placed into commercial distribution packaging.Shockwave has initiated a corrective and preventative action for this event and determined this to be an isolated incident.Shockwave medical remains committed to compliance and will continue to monitor, track, and trend this issue through established quality and post market surveillance processes to ensure sustained effectiveness of implemented controls.The following sections were updated per additional information received on 27mar2026.H6: added annex b: 10, 3331.H6: added annex c: 156, 4244.H6: added annex d: 143.

• 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: 21978001
• Report Number: 3015053838-2025-00066
• Device Sequence Number: 18454825
• Product Code: PPN
• UDI-Device Identifier: 00195451000140
• UDI-Public: (01)00195451000140(17)260731(10)01A240723A
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180958
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 07/31/2026
• Device Model Number: M5IVL4560
• Device Catalogue Number: M5IVL4560
• Device Lot Number: 01A240723A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided; 03/27/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/05/2025; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown