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

Model Number	M5PIVL8060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The device was returned without the distal portion of the catheter including the balloon.The event description confirms that the detached balloon was removed from inside of the patient.All emitters showed signs of wear, indicating that they were fired as expected.The reported failure of the detached balloon was confirmed.Based on the reported information and investigation observations, the cause of the reported failures is unknown due to the condition of the returned device.It is possible that the balloon was not fully deflated and therefore could have made it more difficult to withdraw through the sheath.However, it could not be definitively confirmed with the information available.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 shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac arteries.The physician successfully delivered 240 pulses.While attempting to remove the ivl catheter over the 300cm.014" grand slam guidewire through the 7f pinnacle sheath, the balloon detached from the shaft of the ivl catheter.The physician then removed the sheath and found the detached balloon was not in the sheath.The physician then pulled the grandslam guidewire back slowly and the balloon was removed safely over the grandslam guidewire.A slender sheath was then reinserted and tavr procedure was completed successfully with no complications.There was no patient harm reported.

• 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: 19315857
• Report Number: 3015053858-2024-00046
• Device Sequence Number: 20560820
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)250630(10)82282197
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/14/2024

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: 06/30/2025
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 82282197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: 7F PINNACLE SHEATH - TERUMO; GRAND SLAM 0.14 GUIDEWIRE - ASAHI INTECC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male