MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	S4IVL3040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.Based on the reported event, the balloon successfully delivered 80 pulses in the target lesion before it ruptured.A thrombus was noticed however, it could not be definitively determined whether it was a result of the procedure or not since it was reported that the vessel could not be visualized.An in-dwelling catheter with tissue plasminogen activator (tpa) drip was left inside the patient's vessel to dissolve the thrombus.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
It was reported that a patient underwent a right leg peripheral intervention using shockwave s4 peripheral intravascular lithotripsy (ivl) catheter.Due to poor kidney function the patient procedure had to be done with c02 (contraindication/off label) rather than contrast.After the catheter successfully delivered 80 pulses, the balloon ruptured in the arteries below the knee.After rupture, a thrombus was observed.It was not noticed earlier because of the co2, and it is unknown whether the thrombus was a result of the procedure or not.The vessel could not be visualized as well.An in-dwelling catheter with tissue plasminogen activator (tpa) drip was left inside the patient's vessel to dissolve the thrombus.The patient was required to have an additional hospital stay.No additional information was provided.

• Brand Name: SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): 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: 16707363
• Report Number: 3015053858-2023-00016
• Device Sequence Number: 17560351
• Product Code: PPN
• UDI-Device Identifier: 00195451000324
• UDI-Public: (01)00195451000324(17)240430(10)A220428E
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K198140
• 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): 03/24/2023

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: 04/30/2024
• Device Model Number: S4IVL3040
• Device Catalogue Number: S4IVL3040
• Device Lot Number: A220428E
• 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: 03/24/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown