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

Model Number	C2PIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Hemodynamic instability (4868)
Date of Event	09/24/2024
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid-left anterior descending (lad) artery.It was reported that radial access was obtained using a 6fr sheath, then a guidewire was placed in the lad.A sapphire balloon was inflated twice at 8 atm in the mid-lad, with a subsequent inflation; however, the atm is unknown.The c2+ was then positioned in the lad and inflated to 4 atm and 100 pulses were delivered.This was followed by the placement of an nc neo trek balloon, but the atm for this inflation is unknown.Following angiography, a dissection was observed both proximally and distally in the lad; the dissection grade was not reported.The patient experienced rapid hemodynamic deterioration and coded on the table.The staff indicated that they do not believe the dissection was a result of the c2+ device.No stent was placed during the procedure.
Additional Manufacturer Narrative
The device referenced in this report was discarded and will not be returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Based on the reported information, a dissection was observed via angiography and the patient experienced rapid hemodynamic decline and subsequently expired.There was no c2+ ivl malfunction reported, and the site indicated that they do not believe the dissection was a result of the c2+ device.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 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: 20472813
• Report Number: 3015053858-2024-00121
• Device Sequence Number: 7630210
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)260228(10)01A240220A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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 Expiration Date: 02/28/2026
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 01A240220A
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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: NC NEO TRACK - BALLOON; PHILLIPS - IVUS CATHETER; SAPPHIRE - BALLOON
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female