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

Model Number	C2IVL2512
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Codes	Chest Pain (1776); Restenosis (4576)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an in-patient underwent a percutaneous coronary intervention (pci) to treat a lesion in the left main (lm) coronary artery.During the initial use of the shockwave c2 intravascular lithotripsy (ivl) catheter, the balloon delivered 10 pulses and then the generator displayed error 88.A second ivl was prepped and used, delivered 18 pulses.However, the same error occurred.Four days following the ivl treatment, the patient experienced acute severe chest pain which subsequently caused the treated left main to close abruptly.The physician performed a second pci to open the left main.It was reported that the calcium wasn't fully expanded because of incomplete expansion and due to inadequate calcium modification.The physician successfully treated the closed vessel with stent implantation and post dilatation of the vessel using a non-compliant (nc) balloon.Three days later, the patient suffered a second abrupt vessel closure.To date, there have been no updates on the status of the patient.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical investigation of the device cannot be performed.Based on the reported event, two ivl catheters were used for this procedure.Both catheters displayed error 88 after delivering pulses.However, biomed tested the 2nd ivl and it performed as designed and no error occurred.The reported abrupt vessel closure occurred four days after the ivl treatment, and the patient experienced a second abrupt vessel closure three days later.A review of the manufacturing and test documentation for the 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.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.Reference:2nd ivl device (b)(6), model/catalog # c2ivl2512, lot # b210714c, expiration date: 07/31/2023, manufacturing date: 7/14/2021, udi: (b)(4).

• 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
• MDR Report Key: 16844958
• Report Number: 3015053858-2023-00024
• Device Sequence Number: 6860677
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)24631(10)C220822B
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: 08/31/2024
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: C220822B
• 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: 04/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Sex: Male