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

Model Number	M5PIVL8060
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure, "difficult to remove" was confirmed.The catheter was returned still within the introducer sheath.The device could not be removed from the sheath due to the balloon not being fully deflated.It is possible that the physician did not fully deflate the balloon which prevented the balloon from being pulled through the sheath.The distal marker brand was not received with the device.It cannot be confirmed whether anything remained inside the patient.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.
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the superficial femoral artery (sfa) and popliteal artery.After successful insertion of the catheter in the thigh, the deflated device could no longer be retracted via a 7f sheath.To complete the treatment, a new 7f sheath had to be inserted.This was successful using a body wire, but the balloon catheter may have ruptured the vessel, resulting in a palpable hematoma forming in the final minutes of the procedure.The use of a suture closure system was unable to adequately close the vessel.The subsequent computed tomography (ct) angiography revealed a large retroperitoneal hematoma.The patient became increasingly unstable over a short period of time and required emergency surgery.The procedure was uneventful until the ivl catheter malfunctioned.It was reported that the negative outcome was directly attributable to the complication with the shockwave catheter.The patient stated that the patient had a full recovery post-surgery.

• 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: 22799667
• Report Number: 3015053858-2025-00097
• Device Sequence Number: 15594364
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)261231(10)82325247
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 82325247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: 7F SHEATH - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown