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

Model Number	M5PIVL6060
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The device arrived fragmented with the balloon and distal tip missing.The reported failure of kinked shaft was confirmed.One section of kinks was noted on the outer shaft distal to the distal end of the strain relief additionally, the reported failure of an issue with the 7mm spider embolic protection device was confirmed.The exact cause could not be definitively determined.During investigation, detachment of the balloon was also noted.The balloon and distal tip were missing and not returned.Based on the reported information, the detached balloon and distal tip were successfully removed from the patient.The cause for the detachment is unknown but could possibly be related to the interaction with the 7mm spider embolic protection device.As of the date of this report, there has been no harm to the patient reported.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination has not been performed.Evaluation of the subject device is anticipated but has not yet begun.After the device is received and investigation is completed, a supplemental report will be submitted.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 right superficial femoral artery (sfa).300 pulses were successfully delivered.Upon attempts to withdraw the ivl catheter from the patient, the device became stuck on the 7mm spider wire.There were multiple attempts to retrieve the catheter from the wire.The wire and the catheter were removed together from the patient.During withdrawal, the ivl catheter broke.It is unknown where the breakage occurred and whether there was complete device separation.It was confirmed that no device fragment fell inside the patient.Final angiograms demonstrated an excellent result for the patient without any issue or harm.

• 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: 19724172
• Report Number: 3015053858-2024-00064
• Device Sequence Number: 8275273
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)250331(10)82277280
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 03/31/2025
• Device Model Number: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 82277280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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: 7MM SPIDER WIRE; 7MM SPIDER WIRE - MEDTRONIC
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown