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

Model Number	L6IVL100030
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation.The reported failures of a balloon loss of pressure and detached balloon were confirmed.The device was received in two pieces with a break at the proximal portion of the balloon.A radial tear was also observed.All components were found to be present and accounted for confirming nothing was left inside of the patient.The balloon loss of pressure could possibly be attributed to interaction with patient calcium.The balloon loss of pressure could have prevented the balloon from fully deflating and the radial tear could account for difficulty in removal through the sheath.Force was applied to remove the device along with multiple sheath exchanges causing partial balloon detachment at the distal end.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 l6 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the right and left common iliac arteries.280 pulses were successfully delivered before a balloon loss of pressure occurred.Upon removal, the balloon became detached from the ivl catheter.The proximal end came out over the sheath while the distal tip of the balloon remained in the body and was stuck on the sheath.Snaring was performed to remove the detached portion of the ivl catheter.A dissection/injury to the left cfa was observed after multiple sheath exchanges and snaring of the distal portion of the ivl catheter.The patient was sent from the catheter lab to the operating room (or) for a surgical common fetal artery (cfa) repair.The patient had a successful repair of their cfa and has since been discharged.

• 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
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 18947209
• Report Number: 3015053858-2024-00024
• Device Sequence Number: 20669565
• Product Code: PPN
• UDI-Device Identifier: 00195451000409
• UDI-Public: (01)00195451000409(17)250430(10)A230411A
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K221852
• 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): 03/20/2024

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 Expiration Date: 04/30/2025
• Device Model Number: L6IVL100030
• Device Catalogue Number: L6IVL100030
• Device Lot Number: A230411A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: 10F COOK SHEATH; 7F TERUMO DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female