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

Model Number	C2 IVL2512
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2 coronary lithotripsy (ivl) device was used on a patient who underwent a chronic total occlusion (cto) procedure at the right coronary artery (rca).Access was obtained via femoral artery.Angiography revealed a shelf of proximal nodular calcification and no pre-existing stent was at the target vessel.The vessel was pre-dilated multiple times with both non-compliant and compliant balloons.Reportedly, the physician felt a lot of resistance while advancing the catheter through the shaft to the target vessel.After the ivl balloon delivered 10 pulses, at which time the shaft was observed to be kinked.The shaft did not separate so the physician was able to pull out the kinked catheter with some resistance.A second ivl balloon catheter was used, and the shaft experienced the same resistance, and got stuck in the guiding catheter on the off-ramp of the guide extension.The physician removed it by pulling the entire guiding catheter out.It was then noted under fluoroscopy that there was a dissection at the distal end of the rca.The vessel was very calcified and the ivl balloon was unable to pass through this section.According to the field clinical specialist (fcs), the dissection was left untreated, but the user facility provided the patient with medical management.It was reported it to be a grade d dissection.At the time of this report, the patient was reportedly in stable condition.No additional information was provided.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave for investigation.During visual inspection, one kink was found at approximately 20cm distal from the rx port.The balloon catheter showed evidence of usage but maintained its physical integrity.The reported shaft kink was confirmed.The probable cause for the shaft kink is likely related to multiple manipulations of the device during use for the c2 ivl device.The shaft kink is not believed to be related to the dissection.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.

• 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: 13002439
• Report Number: 3015053858-2021-00030
• Device Sequence Number: 19912653
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)230930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/19/2021

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: 09/30/2023
• Device Model Number: C2 IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A210903D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: COMPLIANT BALLOONS (UNKNOWN MANUFACTURER); GUIDE EXTENSION - UNKNOWN MANUFACTURER; NON-COMPLIANT (NC) BALLOONS (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown