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

Model Number	3.5 X 12MM
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pre-procedure exam: 5 out of 10 chest pain with electrocardiogram (ekg) showing inferior wall st-elevation.After getting verbal informed consent, the patient was prepped and draped in the usual sterile fashion.Access obtained into the right radial artery.Team was working on the mid right coronary artery lesion.Per report: use of 3.5 x 12 shockwave balloon was attempted during st elevation myocardial infarction (stemi) procedure; however, the balloon was defective and could not be inflated and dye exited through the balloon.At this point another shockwave balloon was successfully brought across the entire lesion.The procedure was then completed with no further incident.Outcome: successful shockwave and balloon angioplasty of the mid right coronary artery heavily calcified lesion, with the lesion being reduced from 99% to 50% with thrombolysis in myocardial infarction (timi)-3 flow.Manufacturer response for shockwave intravascular lithotripsy system, shockwave ivl system with the shockwave c2 coronary ivl catheter (per site reporter).Defective device given to field representative.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 19380641
• Report Number: 19380641
• Device Sequence Number: 15338033
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)250531(10)08A230523A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2024
• Report Date (Section F): 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.5 X 12MM
• Device Catalogue Number: C2IVL3512
• Device Lot Number: 08A230523A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 01/30/2024