MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

Model Number	C2PIVL3512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The cause of the type a dissection cannot be definitively determined.Balloon ruptures are a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The shockwave intravascular lithotripsy (ivl) system with the shockwave c2+ coronary ivl catheter generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure not to exceed 4 atm during ivl treatment, and 6 atm for post dilatation.The pressure used for the ivl balloon catheter is much lower than other balloon catheters used in percutaneous coronary intervention (pci), thus the risk associated with loss of balloon pressure during ivl catheter use is negligible.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.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 first ivl catheter delivered a total of 20 ivl pulses before the balloon ruptured.After, a type a dissection was reported.The physician attempted to use a second ivl catheter but was unable to cross after losing the wire position; therefore, the dissection was left untreated.No other balloons or stents were able to cross the lesion despite multiple attempts.Plain old balloon angioplasty (poba) was performed, and the patient was observed in the lab.The dissection was stable, and the patient was admitted to the intensive care unit (icu) for observation.The patient was then transferred to a different hospital for follow-up care and additional procedures.The procedure was successful and there was no additional patient sequelae reported.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY 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: 23806806
• Report Number: 3015053858-2025-00152
• Device Sequence Number: 9360597
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)260731(10)21A240701B
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/15/2025

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: 07/31/2026
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 21A240701B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 6FR EBU 3.5 & 3.75.; 6FR GUIDELINER COAST.; 6FR. SLENDER SHEATH.; GUARDIAN.; MEDTRONIC RESOLUTE ONYX 3X26 STENT.; NC TREK NEO 2.5X12.; NC TREK NEO 3.25X8.; NC TREK NEO 3X8.; PROWATER GUIDEWIRE.; SION BLUE GUIDEWIRE.; TREK 2.5X15.; TREK 3X12.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 80 KG