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

Model Number	C2PIVL3012
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported balloon rupture was confirmed.Based on the reported information and investigation observations, the root cause of the balloon rupture could possibly be attributed to patient calcium and damage caused when the balloon wall comes into close contact with the device emitters.The cause of the dissection could not be definitively determined based on the information available.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.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.
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.

• 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: 23493332
• Report Number: 3015053858-2025-00128
• Device Sequence Number: 8992838
• 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 MANUFACTURER.; NON-COMPLIANT BALLOON - EMERGE.; SHEATH - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White