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

Model Number	C2IVL4012
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546); Sparking (2595)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 coronary lithotripsy (ivl) device was used to treat a patient who underwent a percutaneous coronary intervention (pci) procedure to treat a lesion at the left main (lm), left anterior descending (lad) and the circumflex (cx) arteries.Ivus imaging showed there was calcification on the vessel walls, and no presence of pre-existing stent(s) within the vicinity of the target vessel.The physician did not encounter any resistance while tracking the ivl catheter to the target vessel.Upon delivery of 20 pulses with the ivl catheter, the physician reported pulsing at the catheter hub when the button was pressed to activate ivl.When the ivl balloon was in the left main, the balloon ruptured and dissection was observed under fluoroscopy and ivus; the dissection grade was not reported.Thrombosis was also noted in the lm, lad, and cx so the physician performed thrombectomy and then implanted drug-eluting stent (des) post ivl procedure.The patient had prolonged hospital stay and was discharged to home 3 days later.Additional information was received from medwatch (b)(4) submitted by the user facility.It was reported that the physician was shocked by the ivl balloon catheter when he performed out-of-body test after he pulled out the ivl balloon from the patient's anatomy.
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.Based on the provided information, the dissection was noted after the c2ivl balloon ruptured after delivering 20 pulses.In addition, thrombosis was noted in the left main, lad, and cx arteries.The cause for the balloon rupture and subsequent observed vessel dissection and thrombosis cannot be definitively determined with the information available.The cause for the reported pulsing at the catheter hub cannot be definitively determined without a review of the defective device; however, this observation is unrelated to the reported balloon rupture and dissection.A review of the lot history record (lhr) indicates that the device met all inspection criteria.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.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical for investigation.The reported failures of a balloon rupture and sparking in the hub were confirmed.Based on the investigation observations, the balloon rupture failure is likely attributed to patient calcium.The sparking in the hub failure could possibly be attributed to the manufacturing of the device.It is possible that the wire insulation was accidentally scratched / nicked during assembly, and the wires rubbed against the edge of the hypotube, thus exposing the bare wires, and creating a spark gap in the hub.Though the broken/damaged wire insulation could cause a current leakage, in this case the leakage is contained within the hub and the risk of electrical shock to the user and/or patient is negligible.The exact cause of the dissection and thrombosis could not be determined.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• 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: 13158177
• Report Number: 3015053858-2021-00035
• Device Sequence Number: 4118252
• Product Code: QMG
• UDI-Device Identifier: 00195451000119
• UDI-Public: (01)00195451000119(17)230531
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 05/31/2023
• Device Model Number: C2IVL4012
• Device Catalogue Number: C2IVL4012
• Device Lot Number: A210506H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: DRUG-ELUTING STENT (DES)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White