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

Model Number	M5PIVL6060
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ intravascular lithotripsy (ivl) device was used to treat a lesion located in the popliteal artery.There was difficulty crossing so the physician attempted to remove the ivl device using excessive force.After the device was removed, the balloon was found to have detached from the catheter and was firmly lodged inside the tip of the 6f flexor sheath.The physician also removed the sheath as a unit, and nothing remained inside the patient.Additionally, the patient was reported to have a pre-existing stent implanted in the popliteal artery.The physician decided to treat the stented portion because the distal flow was sub-optimal.The physician was aware that he was using the device off-label.The intended procedure was completed and there were no patient clinical sequelae reported.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For evaluation.The evaluation confirmed the reported failure.The device was returned in two separate parts.The proximal end of the device was still on the guidewire.The distal balloon end was still within the sheath.Based on the reported complaint, the physician knowingly used the device for an unapproved indication.The exact cause of the reported event could not be definitively determined however, user handling could not be ruled out as the contributory cause.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's 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: 16447314
• Report Number: 3015053858-2023-00010
• Device Sequence Number: 5835705
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)240630)10)82254430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

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: 06/30/2024
• Device Model Number: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 82254430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK MEDICAL 6FR FLEXOR SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male