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

Model Number	M5IVL6060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported balloon loss of pressure and subsequent detached catheter component could not be determined as the device was not available for investigation.Therefore, a physical inspection of the device was not possible.It is noted that the patient eventually did fine and was discharged from the hospital.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.
Event or Problem Description
A m5 ivl peripheral catheter was used to treat the sfa (superficial femoral artery).After the third inflation, a balloon loss of pressure occurred.A fragment of the balloon became detached and proceeded downstream.Surgery was performed to remove the detached component from the patient.The physician believes that the balloon likely ruptured due to calcium.The patient is well and has since been discharged.
Additional Manufacturer Narrative
The subject device was received for investigation.The device was returned with the distal portion of the catheter missing.It has been confirmed that the detached portion of the ivl catheter was successfully retrieved from the patient.As of the date of this report, no patient sequelae has been reported.The reported device separation was confirmed.Based on the investigation of the returned components, the cause of the balloon loss of pressure could not be determined.It is suspected that the balloon loss of pressure occurred first, causing device removal difficulties from an unknown source.Force was likely used to withdraw the ivl catheter which caused it to separate.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 M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5 PERIPHERAL 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; santa clara, CA 95054
• MDR Report Key: 15254137
• Report Number: 3015053858-2022-00054
• Device Sequence Number: 12224151
• Product Code: PPN
• UDI-Device Identifier: 00195451000171
• UDI-Public: (01)00195451000171(17)240131(10)82241618
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K203365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 01/31/2024
• Device Model Number: M5IVL6060
• Device Catalogue Number: M5IVL6060
• Device Lot Number: 82241618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown