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

Model Number	M5PIVL6060
Medical Device Problem Codes	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	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical for investigation.It was visually observed that the device was returned in two pieces, but no components were found missing.The reported failure was confirmed.Based on the description of the event, as the m5+ ivl device was being removed through the 6f sheath, the balloon got stuck and caused the outer shaft and the inner member to separate.The cause of the device being stuck within the sheath could not be definitively determined.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.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
It was reported that a shockwave m5+ peripheral intravascular lithotripsy (iv) catheter was used to treat a lesion located in the femoral artery.After the balloon successfully delivered 270 pulses, the physician attempted to pull out the catheter.During the removal of the catheter through the 6f sheath, it got stuck and the balloon detached while it was inside the sheath.It was reported that no excessive force was used during the removal of the catheter.When the sheath was finally removed from the patient, the balloon was inside and was successfully retrieved.

• 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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara 95054
• MDR Report Key: 16308124
• Report Number: 3015053858-2023-00006
• Device Sequence Number: 20355079
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)240630(10)82256760
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/18/2023

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: 82256760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: 6F SHEATH (UNKNOWN MANUFACTURER).
• Patient Age: 63 YR
• Patient Sex: Female