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

Model Number	M5IVL7060
Medical Device Problem Codes	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	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned with the 6f introducer sheath included.A visual inspection of the introducer sheath was preformed and no issues were found.A portion of the balloon was missing including the marker band and distal end.As noted in the event description, the detached ivl catheter components were successfully retrieved from inside the patient.The likely cause for the reported balloon loss of pressure and subsequent detached balloon or catheter component can be attributed to patient calcium and off-label usage.Per the information provided, it was noted that a 6f terumo introducer sheath was used indicating off-label use.The ifu states, "6.5-7.0mm balloon is 7f introducer sheath compatible".The use of a smaller sheath may have contributed to the device separation.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 ivl catheter was used to treat the right iliac.After 246 pulses, a balloon loss of pressure occurred.Contrast hung up in end of balloon that was difficult to remove.When pulling the balloon into the sheath, the distal end of the balloon separated.The ivl catheter including the separated piece came out from the sheath.To date, no patient sequelae has been 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: 14118966
• Report Number: 3015053858-2022-00027
• Device Sequence Number: 4249467
• Product Code: PPN
• UDI-Device Identifier: 00195451000195
• UDI-Public: (01)00195451000195(17)230531(10)A210514A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• 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): 03/23/2022

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: 05/31/2023
• Device Model Number: M5IVL7060
• Device Catalogue Number: M5IVL7060
• Device Lot Number: A210514A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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: .014 300 LENGTH WIRE-UNKNOWN MANUFACTURER; 6F TERUMO PINNACLE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown