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

Model Number	C2IVL3012
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination could not be performed.Based on the provided information, the patient underwent a bypass surgery to remove the devices that got stuck during the procedure.According to the report, the physician believes that the guide catheter deformed the pre-existing stent which led to the guide extension getting stuck and the ivl device unable to be removed.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
It was reported that a patient underwent a percutaneous coronary intervention (pci) procedure to treat a lesion located in the #3 branch and the distal right coronary artery (rca).Access was obtained via the radial artery.After the physician positioned the 6f guidezilla¿ii, the shockwave c2 coronary intravascular lithotripsy (ivl) catheter was advanced towards the target vessel.After the balloon successfully delivered 70 pulses in the # 3 branch, the physician attempted to advance to the distal rca.However, the guide catheter encountered a previously implanted stent which is in the #1 branch.The stent got deformed by the guide and so the physician attempted to remove the ivl catheter from the patient, however, it could not be pulled back and guidezilla simultaneously got stuck.The physician used another guide extension and a guidewire to bail out the stuck devices but were unsuccessful.The devices were retrieved with a bypass procedure.Reportedly, the patient is still in the hospital and has not yet been discharged as of this report.According to the report, the physician believes that the guide catheter deformed the stent which led to the guide extension getting stuck and the ivl device unable to be removed.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 17198728
• Report Number: 3015053858-2023-00038
• Device Sequence Number: 6798981
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)241231(10)A221207D
• 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): 06/15/2023

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: 12/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A221207D
• 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: 06/15/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: 6F GUIDEZILLA¿II - BOSTON SCIENTIFIC; GUIDE EXTENSION - UNKNOWN BRAND/MANUFACTURER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Male