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

Model Number	C2PIVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Vascular Dissection (3160)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
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 dissection, chest pain, and bradycardia could not be definitively determined based on the information available.The physician suggested that the dissection could have been caused by the guidewire prior to shockwave ivl therapy with the shockwave c2+ coronary ivl catheter, or it might have been that the second lesion was already a ruptured plaque, with shockwave ivl possibly exacerbating the situation.The physician reported that the patient outcome would have occurred even without the use of shockwave ivl, and if only percutaneous transluminal angioplasty (pta) and stenting were performed.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 patient underwent treatment using shockwave c2+ ivl coronary catheter system to treat coronary artery.It was reported that the patient experienced a dissection during the procedure.During surgical turndown, the ivl catheter delivered two cycles distally when the patient decompensated.The ivl balloon was moved proximally and an additional two cycles (20 pulses) were delivered.Between each cycle, the ivl balloon was pulled back to allow the patient to recover.After the two proximal cycles, the patient experienced chest pain, and the patient's heart rate slowed into the 30s.A stent was placed from distal to proximal to treat the dissection, and integrilin administered.The patient's heart rhythm normalized to the 70s within a few minutes.The event resulted in extra time in the hospital, and there were no additional patient sequelae reported.
Additional Manufacturer Narrative
The following sections were updated accordingly per additional information received 17-sep-2025: 1) a2 - age at time of the event: 80 year(s) 2) a3a - sex: female 3) b5 - added "the dissection that the patient experienced was classified as grade c.During the procedure, a non-compliant (nc) balloon was used.The patient was discharged." 4) d10 concomitant medical products and therapy dates: added "nc balloon - unknown manufacturer" and "09/04/2025".
Event or Problem Description
Additional information received on 17sep2025: the dissection that the patient experienced was classified as grade c.During the procedure, a non-compliant (nc) balloon was used.The patient was discharged.

• 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: 23080824
• Report Number: 3015053858-2025-00107
• Device Sequence Number: 11923594
• Product Code: QMG
• UDI-Device Identifier: 00195451000010
• UDI-Public: (01)00195451000010(17)261231(10)04A241212B
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 04A241212B
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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: GUIDEWIRE - UNKNOWN MANUFACTURER; NC BALLOON - UNKNOWN MANUFACTURER; STENT - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female