MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IV CATHETER

Model Number	L6IVL090030
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave l6 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the common iliac artery and distal aorta.It was reported that while attempting to advance the balloon catheter over the guidewire, there was some resistance.During removal of the device from the patient, resistance was again encountered.The balloon appeared to be fully deflated prior to removal.However, as it stretched during extraction, it likely drew fluid back in and became stuck on the guidewire.The sheath was withdrawn and the guidewire was cut to facilitate retrieval of the device.The balloon separated and came apart from the catheter as it was being removed.The catheter but was successfully removed using simple traction.There were no catheter fragments retained inside the patient.The procedure was completed without issues, and no patient harm was reported.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.All components were returned and accounted for.No components were noted to be missing.The reported failure was confirmed.A detachment of the outer shaft from the distal hub bond was observed.Based on the reported information and the investigation findings, it is possible that the device became stuck during removal, and the force applied to remove the device from the patient may have caused the detachment.Additionally, the guidewire could not be removed from the catheter.Further investigation into why the guidewire is stuck could not be performed due to the condition of the returned device.The inner member was found to be extremely stretched which caused it to likely bind on the guidewire.The exact cause of the device becoming stuck could not be 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.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IV CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IV 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: 24552666
• Report Number: 3015053858-2026-00020
• Device Sequence Number: 5688754
• Product Code: PPN
• UDI-Device Identifier: 00195451000393
• UDI-Public: (01)00195451000393(17)2700630(10)03A250627A
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K240954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: L6IVL090030
• Device Catalogue Number: L6IVL090030
• Device Lot Number: 03A250627A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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: SHEATH - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown