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

Model Number	C2PIVL3512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751); Hemodynamic instability (4868)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a patient undergoing a multi vessel with percutaneous coronary intervention (pci) to the coronary artery an impella pump was inserted prior to the intervention as planned.It was reported that the physician was able to deliver two cycles for a total of 20 pulses.The physician removed the catheter and reinserted it into the patient to treat a second vessel, at which time a loss of balloon pressure was observed.Reinsertion of the c2+ ivl catheter is outside of the indications for use (ifu).The patient became hemodynamically unstable, evidence by no pressure of the arterial waveform including, bradycardia and st elevation.This was resolved and the patient was given neosynephrine.The ivl catheter was removed, and the intervention was successfully performed with standard balloons and a stent.While in recovery, the patient developed a bundle branch block.The patient is now discharged.
Additional Manufacturer Narrative
The subject device was returned and the balloon rupture failure reported could not be confirmed; however, a noticeable tear on the outer shaft was identified, likely leading to the pressure loss experienced during the procedure.The device usage was off label as it was utilized in conjunction with a stent.The c2 device is specifically indicated for lithotripsy-enabled, low-pressure balloon dilatation in severely calcified, stenotic de novo coronary arteries prior to stenting.The presence of the stent may have contributed to the balloon's rupture.It was noted that the catheter was removed from the body after delivering 2 cycles, only to be reinserted for use in a second vessel.As cautioned in the instructions for use (ifu) (lbl 64191), "ivl catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy treatments.Balloon can be damaged in the process." based on the information provided, the ivl catheter was reinserted into the patient which is outside the device indication for use as the c2+ ivl catheter is a single use device.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.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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 22502353
• Report Number: 3015053858-2025-00084
• Device Sequence Number: 8458739
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)261031(10)02A241010A
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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 Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 02A241010A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: BALLOONS: MANUFACTURER UNKNOWN; IMPELLA PUMP; STENT: MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Female