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

Model Number	M5IVL5060
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	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to successfully treat a lesion in the superficial femoral artery (sfa).While attempting to remove the catheter from the sheath, a detachment occurred, and a fragment of the balloon fell inside the patient.The separation occurred while the balloon was fully deflated.The physician used a specialized device to retrieve and take out the fragment.A second ivl catheter was used to complete the surgery.There was no reported patient harm.The physician attributed the separation to quality issues.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the detachment could not be definitively determined based on the information available.There was no patient harm.The physician attributed the separation to quality issues.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.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of catheter detachment was confirmed.The device was returned broken and separated into two pieces.There were no components found missing.The break of the catheter shaft occurred 3 inches from the distal end of the ivl catheter.All emitters showed signs of wear, indicating that they were fired as expected.The pleat and folds of the balloon remain prominent possibly indicating that the balloon may not have been inflated or may not have been completely inflated.There was no physical damage noted on the balloon surface and catheter tip.The cause of catheter detachment during the medical procedure is unknown.Based on the investigation observations and reported information, it is possible that the balloon got stuck inside the sheath and the force used to remove the device would have caused detachment of catheter components.

• 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: 21023666
• Report Number: 3015053858-2024-00135
• Device Sequence Number: 8367739
• Product Code: PPN
• UDI-Device Identifier: 00195451000157
• UDI-Public: (01)00195451000157(17)250228(10)A230221D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 02/28/2025
• Device Model Number: M5IVL5060
• Device Catalogue Number: M5IVL5060
• Device Lot Number: A230221D
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: 14' GUIDEWIRE - UNKNOWN MANUFACTURER; 6F SHEATH - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male