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

Model Number	C2IVL2512
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.Visual inspection of the emitters showed signs of wear, an indication that they have been fired.During the investigation, it was noted that one half of the emitter outer band was dislodged from its location, and it could not be located inside the balloon.The other half was found located at the distal balloon tip.Based on the investigation of the device, the reported device failure is confirmed.The reported balloon loss of pressure was also confirmed.There was a longitudinal tear starting from emitter 1, extending to 9mm.The likely cause of the balloon loss of pressure could be attributed to patient calcium a review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device 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 shockwave c2 coronary intravascular lithotripsy (ivl) balloon was used to treat a de novo lesion in the coronary artery.After delivering 30 pulses, a balloon loss of pressure occurred.Post ivl treatment, intravascular ultrasound (ivus) was initiated to view the lesion.An image of a foreign particle was observed in ivus which the physician suspected it to be an ivl material that broke off.Another ivl was prepped and used to successfully complete the intended procedure.Another ivus imaging was taken after the use of the second device.It was reported that the foreign particle appeared to be on a different site from the first image that was taken.No additional information was provided.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PRODUCT CODE: QMG (CORONARY)
• 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 ; 8777754846
• MDR Report Key: 17826173
• Report Number: 3015053858-2023-00056
• Device Sequence Number: 6161370
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)250531(10)11B230502A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: 11B230502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: INTRAVASCULAR ULTRASOUND (IVUS) CATHETERS - UNK MF.
• Patient Sex: Unknown