MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	L6IVL100030
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave l6 peripheral intravascular lithotripsy (ivl) catheter was used to treat a calcified lesion in the iliac arteries.The physician selected a 7fr sheath for the ivl catheter which is smaller than the recommended sheath size of 8fr for a 10.0mm catheter per the device instructions for use.During the procedure, 300 pulses were successfully delivered.Upon removal of the ivl catheter, the catheter became stuck in the 7fr sheath and was not able to be removed.The physician then used a 20cc syringe to pull negative and attempted to pull out the ivl catheter but ultimately had to pull the entire sheath out.The balloon did not separate from the catheter[?]there was no kinking or fragmentation of the device, and the balloon remained intact.When the physician put the sheath back in, they noticed they had damaged the tip of the sheath.Therefore, a new sheath was opened but could not be successfully navigated back through the access site.An angiogram revealed a perforation of the external iliac artery.Subsequently, brachial access was obtained, and a viabahn stent was deployed to seal the perforation, followed by post-dilation ballooning.A post-dilation balloon was used after the viabahn stent was placed.After the procedure, the patient underwent a ct scan to assess any further bleeding.The patient was then brought back the next day to extend the stent, and it was reported that the patient was doing much better.The physician accepted responsibility for the sheath selection.The physician discussed the possibility that the balloon might not have been fully deflated before withdrawal, but did not speculate on what caused the perforation.The patient experienced a drop in blood pressure that night, necessitating a second procedure where an additional stent was placed.
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 perforation could not be definitively determined based on the information available.The physician selected a 7fr sheath for the ivl catheter which is smaller than the recommended sheath size of 8fr for a 10.0mm catheter per the device instructions for use.The physician accepted responsibility for the sheath selection.The physician discussed the possibility that the balloon might not have been fully deflated before withdrawal, but did not speculate on what caused the perforation.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 L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE L6 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: 21914537
• Report Number: 3015053838-2025-00062
• Device Sequence Number: 7266900
• Product Code: PPN
• UDI-Device Identifier: 00195451000409
• UDI-Public: (01)00195451000409(17)261130(10)06A241111A
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: L6IVL100030
• Device Catalogue Number: L6IVL100030
• Device Lot Number: 06A241111A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: 5FR TERUMO SHEATH; 7FR TERUMO SHEATH; POST-DILATION BALLOON - UNKNOWN MANUFACTURER; VIABAHN STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male