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

Model Number	C2PIVL2512
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination has not been performed.Evaluation of the subject device is anticipated but has not yet begun.After the device is received and investigation is completed, a supplemental report will be submitted.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 left anterior descending artery (lad).A 2.5mm non-shockwave compliant balloon was used for pre-dilation and ruptured during the procedure followed by ivl.During the procedure, the ivl balloon ruptured while fully inflated.Due to severe calcification, a portion of the balloon detached and became lodged in the artery.Despite multiple efforts to retrieve the balloon through both endovascular and open-heart methods, retrieval was unsuccessful.The patient underwent emergent bypass surgery.The procedure was completed, and the patient is currently recovering, although the ivl balloon remains in place.No patient demographics or medical information was provided at the time of the report.Shockwave medical is attempting to gather additional information.
Additional Manufacturer Narrative
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 detachment could not be definitively determined based on the information available.The following sections have been updated accordingly: d9: "is this device available for evaluation?" has been updated to "no".H6: the following annex codes have been updated: type of investigation (b): 4114.Investigation findings (c): 114.Investigation conclusion (d): 4315.

• 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 95054
• MDR Report Key: 22290140
• Report Number: 3015053858-2025-00079
• Device Sequence Number: 8374378
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)261031(10)01A241024B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 01A241024B
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: 2.5MM COMPLIANT BALLOON - MANUFACTURER UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown