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

Model Number	M5IVL7060
Medical Device Problem Codes	Difficult to Remove (1528); 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	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The device was returned with the distal portion of the catheter missing.The reported failure was confirmed, and the balloon rupture may have happened first.Afterward as the device is being removed it is possible that it was caught onto something and with force was used to withdraw the device that caused it to separate.It was noted that the device was initially used for 120 pulses, removed from the body and then reinserted into the body for further pulsing which is outside the instructions for use for the m5 ivl catheter.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
An m5 ivl peripheral catheter was used accessing thought the left femoral artery to treat the left and right iliac artery.A balloon ruptured may have occurred and when removing the ivl catheter from the body, detachment of the balloon occurred and were unsuccessful to snare.The detached portion of the ivl catheter was successfully trapped with a gore vbx stent.To date, no patient sequelae has been reported.It was noted that the device was initially used for 120 pulses, removed from the body and then reinserted into the body for further pulsing that can cause the balloon to be damaged in the process.

• 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 Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 15996614
• Report Number: 3015053858-2022-00068
• Device Sequence Number: 5922590
• Product Code: PPN
• UDI-Device Identifier: 00195451000195
• UDI-Public: (01)00195451000195(17)231031(10)82235883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 10/31/2023
• Device Model Number: M5IVL7060
• Device Catalogue Number: M5IVL7060
• Device Lot Number: 82235883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: GORE VBX STENT GRAFT.; GUIDEWIRE: 0.014" CHOICE PT.; SHEATH: 6 6F PINNACLE DESTINATION GUIDING SHEATH.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female