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

Model Number	C2PIVL4012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Hematoma (1884); Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
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 dissection, pericardial effusion, atrial fibrillation, and hematoma could not be determined based on the information available.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
Two shockwave c2+ coronary intravascular lithotripsy catheters were successfully used to treat lesions in the coronary arteries.This report is for the first catheter reported (refer to mdr 3015053858-2024-00052 for the second catheter).The first c2+ catheter was used to treat a lesion in the right coronary artery (rca) and successfully delivered 60 pulses.The second c2+ catheter was used to treat a lesion in the left anterior descending artery (lad) and successfully delivered 20 pulses.There were no device malfunctions reported for either catheter.After the procedure was performed on (b)(6) 2024, the patient was found to have type a aortic dissection after complaints of chest pain.The patient was then treated with iv esmolol and tight blood pressure control.The patient was admitted to continue observation.0n (b)(6) 2024, a few weeks after the initial procedure was performed, the patient presented to the emergency department (ed) with chest pain.The patient converted into atrial fibrillation with rapid ventricular response (rvr).The patient was then placed on ditiazem and converted back to normal sinus rhythm.Additionally, on that same day, a computed tomography angiography (cta) scan was completed and a moderate to large pericardial effusion was noted.The patient was transferred and admitted.Pericardiocentesis with drain placement was performed.The patient felt much improved and was discharged on (b)(6) 2024.On (b)(6) 2024, the patient presented again to the emergency department (ed) with chest pain.The patient converted into atrial fibrillation with rapid ventricular response (rvr).The patient was then placed on ditiazem and converted back into normal sinus rhythm.On that same day, a cta scan and transthoracic echocardiogram (tte) scan were completed.Moderate to large pericardial effusion and hematoma were noted.The patient was then transferred and admitted.Pericardial window procedure was performed, and the patient was given medication.The patient felt improvement and was discharged on (b)(6) 2024.

• 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: 19397697
• Report Number: 3015053858-2024-00051
• Device Sequence Number: 20595369
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)250831(10)01A230811A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• 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): 05/24/2024

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: 08/31/2025
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 01A230811A
• 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: 04/25/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• 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: ONYX FRONTIER DRUG ELUTING STENT (DES) - MEDTRONIC.; ONYX FRONTIER DRUG ELUTING STENT (DES) - MEDTRONIC.; ONYX FRONTIER DRUG ELUTING STENT (DES) - MEDTRONIC.; POST-STENT DILATATION BALLOON -UNKNOWN MANFACTURER.; POST-STENT DILATATION BALLOON -UNKNOWN MANFACTURER.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White