MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER; SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	4.0 X 12MM
Medical Device Problem Codes	Failure to Cycle (1142); Off-Label Use (1494)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a procedure to treat a lesion in the carina bifurcation site within the coronary artery with a shockwave c2 coronary intravascular lithotripsy (ivl) catheter.According to the report, the ivl balloon pulsed inside a pre-existing stent which is an unapproved indication and considered off-label.Accordingly, the ivl balloon had delivered 10 pulses before error 88 appeared.All the connections were rechecked and the ivl balloon was re-prepped multiple times but were unsuccessful.The procedure was completed with a cutting balloon however, the patient was reported to have developed a clot and experienced a thromboembolic event.The clot was treated with tirofiban administered intravenously.The patient was transferred to the intensive care unit (icu) and it is currently doing well.
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 information, the ivl balloon had delivered 10 pulses before error 88 appeared.The procedure was completed with a cutting balloon however, the patient was reported to have developed a clot and experienced a thromboembolic event.The clot was treated with tirofiban administered intravenously.The cause of the clot could not be definitively determined.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.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.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported device failure could not be replicated.The cause of the reported error 88 message could not be determined.All emitters showed signs of wear, indicating that they were fired as expected.There was no physical damage noted on the balloon surface.The returned device successfully delivered 20 pulses without any error messages.Per the reported information, the device was used off-label as the balloon was pulsed inside a stent and the c2 device is only indicated for use in de novo coronary arteries prior to stenting.The off-label usage cannot contribute to the reported err88 malfunction.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.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.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE C2 CORONARY 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: 18116590
• Report Number: 3015053858-2023-00064
• Device Sequence Number: 6874657
• Product Code: QMG
• UDI-Device Identifier: 00195451000119
• UDI-Public: (01)00195451000119(17)240331(10)B220325B
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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 Expiration Date: 03/31/2024
• Device Model Number: 4.0 X 12MM
• Device Catalogue Number: C2IVL4012
• Device Lot Number: B220325B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 05/05/2025
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/22/2023; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.014" GUIDEWIRE - UNKNOWN MANUFACTURER; 6F GUIDING CATHETER - UNKNOWN ; CUTTING BALLOON - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male