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

Model Number	M5PIVL7060
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	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation, but it arrived missing the distal tip and marker band.The other component showed signs of the device firing as expected.The balloon was found separated distally, 129.3 cm from the strain relief.While the reported balloon detachment was confirmed, the condition of the returned device prevented further testing and analysis.As a result, the root cause of the balloon detachment could not be definitively determined based on the available information and the condition of the device.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 being used to treat an iliac lesion.The physician was treating the right iliac lesion which was accessed through the right formal artery using the ivl when the distal portion of the balloon detached during an adjustment of the catheters position within the artery.The proximal portion of the catheter and balloon were successfully retrieved with issue, while the distal balloon portion remained on the.014" guidewire, was removed using a snare.The number of pulses delivered before the detachment is unknown.The physician noted that there was no resistance during the initial advancement or adjustment of the catheter within the artery.The procedure was completed using a standard peripheral angioplasty balloon.There was no patient harm reported as a result of the reported event.

• 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: 20465893
• Report Number: 3015053858-2024-00120
• Device Sequence Number: 7603078
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)250430(10)82281846
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/16/2024

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: 04/30/2025
• Device Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82281846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: ANGIOPLASTY BALLOON - MANUFACTURER UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown