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

Model Number	C2IVL4012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary arteries.The patient presented with st-segment elevation myocardial infarction (stemi) with a 100% occluded right coronary artery (rca).Prior to ivl, they used thrombectomy and balloons.Calcium was seen on the intravascular ultrasound (ivus).While ivl therapy was being delivered, the patient went into torsades de pointes and ventricular fibrillation.The patient was successfully defibrillated back into normal sinus rhythm (nsr) and the procedure was completed with a stent.There was no ivl device malfunction reported.The patient is currently stable.
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 torsades de pointes and ventricular fibrillation that occurred during ivl treatment could not be definitively determined based on the information available.It was reported that the patient was successfully defibrillated back to normal sinus rhythm and there were no additional sequelae reported.There was no report of any device malfunction.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 c2 coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary arteries.The patient presented with st-segment elevation myocardial infarction (stemi) with a 100% occluded right coronary artery (rca).Prior to ivl, they used thrombectomy and balloons.Calcium was seen on the intravascular ultrasound (ivus).After 2 pulses were delivered, the patient went into torsades de pointes and ventricular fibrillation.The patient was successfully defibrillated back into normal sinus rhythm (nsr) and the procedure was completed with a stent.There was no ivl device malfunction reported.The patient is currently stable.The physician states that it is difficult to determine what may have caused the event.According to the physician, the patient defibrillated and came right out of ventricular fibrillation.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (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 (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: 19570928
• Report Number: 3015053858-2024-00059
• Device Sequence Number: 4160068
• Product Code: QMG
• UDI-Device Identifier: 00195451000119
• UDI-Public: (01)00195451000119(17)250228(10)A230216D
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: C2IVL4012
• Device Catalogue Number: C2IVL4012
• Device Lot Number: A230216D
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Male