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

Model Number	C2PIVL3012
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two shockwave c2+ coronary intravascular lithotripsy (ivl) catheters were used during a procedure to treat the patient's coronary artery.Pre-dilation was performed with a 2.0 semi-compliant balloon, followed by the first shockwave c2+ coronary intravascular lithotripsy (ivl) catheter (b)(6).Access was gained via the radial artery.No resistance was encountered while tracking the catheter over the guidewire or through the sheath.The balloon pressure was increased to 2 atm, but then a loss of pressure was observed.Blood was noted in the indeflator, indicating that the balloon had ruptured.The shockwave balloon was removed intact.A second shockwave c2+ coronary intravascular lithotripsy (ivl) catheter (b)(6) was opened.Although it was adequately prepped and delivered 10 pulses, this catheter would not advance to the lesion.An angiogram was performed revealing a dissection.The physician then proceeded with semi-compliant and non-compliant balloons which were able to cross the lesion.Difficulty occurred while advancing to the lesion, with no kink or device breakage observed.It was noted that the patient had tortuous and calcified anatomy.The patient was subsequently transferred out on the same day for bypass surgery to the left anterior descending (lad) artery due to a flow-limiting dissection.The patient was stable at the time of the transfer.The status of the patient post bypass surgery is unknown.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported code unable/difficult to advance lesion was confirmed.Based on the reported information and investigation observations, the root cause of the reported code unable/difficult to advance lesion could possibly be attributed to tortuous anatomy, a tight lesion, and/or a blockage in the vessel.The cause of the dissection could not be definitively determined based on the information available.Per shockwave medical safety, the dissection is possibly device related to this device.It is not clear if the first or second catheter caused the dissection.It is more likely it was related to the first catheter since this second catheter did not actually reach the site.This is procedure related.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.

• 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 95054
• MDR Report Key: 23493340
• Report Number: 3015053858-2025-00129
• Device Sequence Number: 18385805
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)270228(10)04A250212B
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/06/2025

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: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 04A250212B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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: 2.0 MM SEMI-COMPLIANT BALLOON - EMERGE.; GUIDEWIRE - UNKNOWN MFR.; NON-COMPLIANT BALLOON - EMERGE.; SHEATH - UNKNOWN MFR.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White