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

Model Number	C2PIVL3512
Medical Device Problem Codes	Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Reduced Blood Flow (4598)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sixty pulses were delivered.
Additional Manufacturer Narrative
The following sections were updated per additional information received 30mar2026: a2: age at the time of the event initially entered as 20 years old should be corrected to "unknown".A3a: sex is male.B5: added new information received on 30mar2026.B7: added medical history.D10: added concomitant medical products and therapy dates.
Event or Problem Description
It was reported that a shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used during a procedure to treat a lesion in the proximal left anterior descending (lad) artery under an expanded stent.The physician was aware of the off-label use as the shockwave c2+ ivl catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.During the procedure, the balloon ruptured, which was indicated by blood in the inflator.Following the balloon rupture, the distal portion of the balloon deflated while the proximal portion remained inflated and occlusive.There was no flow around the proximal end of the stent.The physician was unable to pull out the balloon because the balloon was inflated.The physician eventually deflated the balloon by applying negative pulls several times and was able to remove it without patient harm.A second ivl balloon was then used to complete the procedure without incident.The physician was aware the use of the device was off-label, although he felt it was necessary because of the calcium burden behind the stent.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Per the reported information, the device was used off label as there was a stent present and the c2+ device is only indicated for use in de novo coronary arteries prior to stenting.The presence of the stent could have contributed to the balloon rupture.However, the balloon rupture cannot be confirmed without a review of the returned device.It was reported that the c2+ coronary ivl catheter was used to treat a lesion in the coronary artery under an expanded stent which is off-label per the device instructions for use.The instructions for use state "shockwave intravascular lithotripsy (ivl) system with the shockwave c2+ coronary ivl catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting." 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, CA 95054
• MDR Report Key: 24783751
• Report Number: 3015053858-2026-00035
• Device Sequence Number: 9935523
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)271231(10)01A251215B
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/17/2026

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: 01A251215B
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: 6 FR SHEATH RIGHT RADIAL - UNKNOWN MANUFACTURER.; FIELDER XT 014 WIRE - ASAHI INTECC.; UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male