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

Model Number	C2IVL3012
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was kept by the hospital after the procedure therefore, a physical examination could not be performed.Based on the provided information, the patient had to undergo additional surgery for the removal of the detached ivl catheter.After the removal of the ivl catheter surgery, patient is doing well.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all swmi's acceptance criteria prior to shipping.The device successfully delivered 10 pulses, so this is not an out-of-the-box failure.The exact cause for the device separation could not be determined, but the physician stated that it may have "possibly got hung up on a shelf of calcium".Shockwave medical 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 ivl coronary catheter was used to treat a heavily calcified left anterior descending (lad) coronary artery.Femoral access was gained and ivus was used.Physician also used csi prior to the ivl catheter.One cycle of shockwave ivl pulses was delivered and the ivl catheter was attempted to be withdrawn from the patient.Attempts to remove the ivl catheter were unsuccessful, and a portion of the ivl catheter broke off inside the patient.It was noted that the physician then tried to snare the detached catheter but was unsuccessful.The physician stated that the ivl catheter possibly got hung up on a shelf of calcium.No excessive force used during device removal/device manipulation.The patient was scheduled for another procedure to surgically remove the detached catheter.Following the case, the patient was stable in icu.It was reported that the patient underwent open heart surgery a few days following the ivl procedure, and the ivl catheter successfully removed.Patient is doing well, and no additional patient sequelae has been reported.

• 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: 14949908
• Report Number: 3015053858-2022-00039
• Device Sequence Number: 14576186
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240131(10)A220125E
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220125E
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: SNARE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male