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

Model Number	C2PIVL3512
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Shock (2072); Reduced Blood Flow (4598)
Date of Event	08/31/2024
Type of Reportable Event	Death
Event or Problem Description
Two (2) shockwave c2+ coronary intravascular lithotripsy (ivl) catheters were used to treat a lesion in the coronary arteries.The first catheter (c2pivl4012) was prepped using 100% contrast which is considered off-label (instructions for use indicate 50/50 contrast/saline medium).The physician delivered 2 pulses before an error 81 (catheter issue indicating resistor values from catheter do not match catheter data table) was observed.A second catheter (c2pivl3512) was prepped also using 100% contrast and error 81 was observed again.Generator troubleshooting did not resolve the error.Despite the catheter errors, the physician was able to restore blood flow and place 2 stents.However, the patient decompensated with a heart attack as they were pulled off the table.Following the use of an impella heart pump, the patient went into shock and expired.It was reported that the physician does not believe that the shockwave ivl catheter lead to the patient's death.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.The cause of the catheter errors, reduced blood flow, decompensation, shock, and subsequent patient death could not be definitely determined based on the information available.It was reported that both catheters were prepped using 100% contrast which is considered off-label (instructions for use indicate 50/50 contrast/saline medium).It was also reported that the physician does not believe that the shockwave ivl catheter lead to the patient's death.The patient was reported to be extremely sick, and his heart could not recover from the heart attack.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 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 PLUS 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: 20356451
• Report Number: 3015053858-2024-00115
• Device Sequence Number: 7208879
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)13A231207A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• 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): 10/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 13A231207A
• 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: 09/03/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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: UNKNOWN MANUFACTURER - STENTS (X2).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male