MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER

Model Number	M5PIVL7060
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failures of detached catheter component and inability to remove the catheter were confirmed.The catheter was returned with the distal portion of the device detached and missing.The detachment occurred proximal to the proximal marker band.Per the reported information, it was noted that the catheter became stuck, and detachment occurred when force was used to try to remove the device.Per the ifu, it is noted: "do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury." the cause of the device becoming stuck could not be definitively determined.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
It was reported that a shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used during a procedure to treat lesions in both iliac arteries.The surgeon used a 7.0mm m5+ catheter to perform ivl on both iliac arteries via an up-and-over approach over a boston scientific 0.014" thruway wire, delivering a total of 170 pulses across both iliacs (left external and common, and right common).Following deflation of the balloon, the ivl catheter was attempted to be removed and became stuck.The surgeon applied increased traction and nearly all of the device was retrieved, but the balloon portion remained inside the patient, evidenced by the balloon markers.Multiple attempts to snare and retrieve the retained portion using two en snare devices were unsuccessful.Multiple viabahn stents were placed in the aorta and bilateral iliacs, followed by balloon angioplasty to treat the disease and pin the retained portion of the balloon against the vessel wall.There was no report of any patient harm that occurred.The patient did well, stayed overnight, and was discharged the next day.
Additional Manufacturer Narrative
Section h4 device manufacture date has been corrected to 07/01/2025.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL 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: 23951802
• Report Number: 3015053858-2026-00001
• Device Sequence Number: 10683451
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)270731(10)82343220
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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 Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82343220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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: 0.014" THRUWAY WIRE - BOSTON SCIENTIFIC.; 2X EN SNARE - MERIT MEDICAL SYSTEMS, INC.; STENTS - VIABAHN.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female