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); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation and a physical examination was performed.The reported inability to remove the device was unable to be confirmed due to the condition of the returned device.The reported detached catheter component was confirmed.Only the proximal portion of the device was returned so the exact cause of the reported complaint could not be definitively determined.Per the reported information, it was noted that the device was used for treatment within a stent.Per the ifu, the device is indicated for use in "de novo coronary arteries prior to stenting." the presence of the stent could have contributed to the to the inability to remove the device.A review of the lot history records (lhrs) and test documentation did not show any issues with the manufacturing of the devices.The devices passed all shockwave medical, inc.Criteria prior to being released for distribution.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
A c2 coronary ivl catheter was used to treat the left anterior descending artery (lad).Access to the target lesion was obtained via the radial artery.The ivl balloon delivered 30 pulses inside a pre-existing stent.Upon removal of the ivl catheter, it became stuck in the vessel.The ivl catheter became detached and the physician encountered difficulties in removing the detached component.The physician inserted an impella ventricular assist device.However, the patient's cardiac output decreased.During this time, the patient started exhibiting symptoms that required being transferred to the operating room (or).The patient underwent thoracotomy to retrieve the detached portion of the ivl catheter and a coronary artery bypass graft (cabg) was also performed.It was also reported that the lad was dissected due to the manipulation of the catheter to remove it.The patient is reported to be recovering well.

• 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 (Section G): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santaclara, CA 95054 ; 8777754846
• MDR Report Key: 18608725
• Report Number: 3015053858-2024-00003
• Device Sequence Number: 2662325
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)250331(10)RRB230330G
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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: 03/31/2025
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: RRB230330G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPELLA VENTRICULAR ASSIST DEVICE - UNKNOWN MFR
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown