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	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	05/29/2025
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 perforation and pericardial effusion could not be definitively determined based on the information available.There was no ivl device malfunction reported.The physician noted that that patient's slow recovery was a result of his comorbid status (heart failure and aortic stenosis etc.) and did not attribute it to the incident.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.120 ivl pulses were successfully delivered.It was reported that there was a perforation of a large nodular calcium.To stop the bleeding, the physician deployed a 4.0 x15 abbott trek balloon across the area at low pressure to temporarily stop extravasation while the team obtained a covered stent.The trek balloon was then removed and a 3.5x15 biotronik papyrus stent was implanted across the area and post dilated with a 3.5 x15 abbott trek nc balloon.A follow-up angiogram revealed complete resolution of the extravasation.Additionally, a follow-up echocardiogram revealed a 1.5 cm "small" area of effusion in the pericardial space.The doctor then inserted a pericardial drain and drained a total of 150ml of blood overnight.The pericardial drain was removed 2 days later.The patient was discharged the following weekend.The physician noted that patient's slow recovery was a result of his comorbid status (heart failure and aortic stenosis etc.) and did not attribute to the incident.

• 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: 22290365
• Report Number: 3015053838-2025-00077
• Device Sequence Number: 15570156
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)261031(10)01A241029B
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 01A241029B
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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: 3.5 X 15 BIOTRONIK PAPYRUS COVERED STENT; 3.5 X15 ABBOTT TREK NC BALLOON; 3.5X18 ABBOTT XIENCE SKYPOINT STENT; 4.0 X15 ABBOTT TREK BALLOON; ABBOTT WIGGLE WIRE; ASAHI MINAMO WIRE; CORDIS XB 3.5, 1.0 SAPHIRE BALLOON
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male