MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR (IVL) LITHOTRIPSY SYSTEM; INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER

Model Number	M5IVL6060
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc., and the reported device separation was confirmed.According to the reported event, the distal tip of the balloon had detached while it was being removed from introducer.The tip remained in the patient's femoral artery where the physician incised the artery to remove it.Based on the device investigation results, it is possible that upon removal of the device, the tip was caught on something which likely caused it to detach from the balloon.A review of the manufacturing and test documentation for the 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.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
It was reported that a shockwave m5 peripheral intravascular (ivl) lithotripsy catheter was used during a procedure to treat a lesion in the femoral artery.During the treatment, the ivl balloon ruptured after 6 cycles.When the physician pulled the catheter out of the introducer, it was observed that the tip was missing.Reportedly, the tip remained in the femoral artery and the physician had to incise the artery to surgically remove the tip.The physician did not use another ivl as the treatment was deemed complete.Additionally, it was reported that the patient did not have to stay in the hospital.

• Brand Name: SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR (IVL) LITHOTRIPSY SYSTEM
• Common Device Name: INTRAVASCULAR (IVL) LITHOTRIPSY CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara 95133
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara 95054
• MDR Report Key: 16955277
• Report Number: 3015053858-2023-00025
• Device Sequence Number: 19667950
• Product Code: PPN
• UDI-Device Identifier: 00195451000171
• UDI-Public: (01)00195451000171(17)230731(10)A210721A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K203365
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 07/31/2023
• Device Model Number: M5IVL6060
• Device Catalogue Number: M5IVL6060
• Device Lot Number: A210721A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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
• Patient Sex: Unknown