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

Model Number	C2PIVL2512
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2025
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 left anterior descending artery (lad) and got stuck.It was reported that the shaft of the catheter was lodged in the patient's aorta, and the balloon remained stuck in the lad.The patient had a prior left internal mammary artery (lima) graft, which was successfully reopened during the procedure.It was reported that due to the balloon being trapped in the lad, the clinical team proceeded to intervene on the lima and placed a stent in the left main artery to ensure continued blood flow and vessel patency.Additional information was provided on may 23,2025 indicating that a 7f catheter was used for device delivery and that the detachment occurred intraprocedural.It was also noted that the balloon was fully deflated prior to the attempted removal.After the detachment was observed, a snare was used to retrieve the lodged shaft of the catheter, but efforts were unsuccessful.The small piece remains in the patient and is expected to become endothelialized over time.The patient was discharged without further complications.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The root cause of the detachment and difficulty in removing could not be definitively determined based on the information available.The physician noted that the detached portion of the device remains in the patient.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 shockwave medical, inc.Acceptance criteria prior to shipping.

• 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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 22188680
• Report Number: 3015053858-2025-00071
• Device Sequence Number: 15596033
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)260930(10)31A240928B
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: 09/30/2026
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 31A240928B
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2024
• 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: STENT- MANUFACTURE UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown