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

Model Number	C2IVL3012
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Reduced Blood Flow (4598)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure, error 88, could not be replicated.All emitters showed signs of wear, indicating that they were fired as expected.Testing of the device demonstrated that the catheter successfully delivered 80 pulses without any error messages.The cause of the slow flow and myocardial infarction could not be definitively determined with the information available.The physician believes there is a casual relationship between the ivl device and st-elevation.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 arteries.After 20 pulses were delivered at 4 atm, error 88 occurred.No-reflow and st elevation was fluoroscopically observed at lesion #6 from just proximal to distal.After a thrombus aspiration catheter was used, a 2.5 balloon catheter (bc) was inflated, and blood flow was observed.A 2.5 x 26 mm stent and a 3.0 x 26 mm stent were placed at lesion#7 and lesion #6.The flow was improved to thrombolysis in myocardial infarction (timi)2 (slow flow) and the procedure was completed.After the procedure, the creatine kinase (ck) value increased to 2000 but then improved.The patient underwent additional hospitalization to improve blood flow and was discharged from the hospital a few days after the index procedure.The physician believes there is a casual relationship between ivl and st elevation.

• 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: 20306103
• Report Number: 3015053858-2024-00109
• Device Sequence Number: 20781534
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)250930(10)02A230901A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 09/30/2025
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: 02A230901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown