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

Model Number	C2PIVL3012
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160); Reduced Blood Flow (4598)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Two shockwave c2+ intravascular lithotripsy (ivl) catheters were used to treat a nodular de novo lesion in the coronary artery via the femoral artery.It was reported that the first balloon ruptured after 40 pulses.A second ivl balloon was used, which also ruptured after 60 pulses (mfr#3015053838-2025-00047).Ivus imaging revealed a dissection in the vessel.The physician inserted a balloon pump to complete the procedure.Additional information received indicated that there was some reflow but no dissection, and the patient experienced chest pain, leading to the insertion of a balloon pump.The distal wire was subintimal, and reflow was corrected with a balloon, stent, and angio sculpt.Additional information was provided indicating that no pre-dilation was performed, and a xience drug-eluting stent (des) was implanted post-ivl.Shockwave medical is attempting to gather additional information related to this event and patient current status.
Additional Manufacturer Narrative
No device is expected to be returned; however, shockwave is attempting to gather additional information related to this event.A final report will be provided with a summary of additional information and final investigation results.
Additional Manufacturer Narrative
This follow-up report is to clarify that no dissection occurred and therefore annex e codes have been updated accordingly.
Event or Problem Description
Shockwave medical received additional information confirming that there was slow reflow, but no dissection related to the event.
Additional Manufacturer Narrative
This follow-up report is to update the annex b, c, and d codes.The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the balloon rupture and subsequent slow reflow and chest pain could not be definitively determined based on the information available.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.Complaints will continue to be monitored for trending purposes.

• 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
• MDR Report Key: 21540569
• Report Number: 3015053838-2025-00046
• Device Sequence Number: 20845821
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)260831(10)03A240820B
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 08/31/2026
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 03A240820B
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 03/05/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/02/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: ANGIO SCULPT - PHILIPS; XIENCE DRUG-ELUTING STENT (DES) - ABBOTT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown