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	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was being used to treat an unknown lesion.After successfully delivery of ivl pulses, the physician attempted to remove the catheter from the patient and encountered difficulties.Using force, the balloon became stuck in the 6fr pinnacle introducer sheath, leading to balloon detachment from the ivl catheter.The detached ivl balloon remained contained within the 6f sheath, and the sheath and detached balloon were successfully removed from the patient without incident.The sheath was changed for a new sheath, and the procedure was completed with no patient sequelae reported.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination cannot be 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.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The device was received with partial balloon and distal end missing.Based on the event details, all ivl catheter components were successfully retrieved from inside of the patient.The reported difficulties removing the ivl catheter from the sheath could not be confirmed due to the condition of the returned device.The reported balloon detachment was confirmed.The cause of the reported failures is unknown due to the condition of the returned device.Based on the reported event, the physician noted that the balloon became stuck in the sheath, leading to balloon detachment from the ivl catheter.The detached ivl balloon remained contained within the 6f sheath, and the sheath and detached balloon were successfully removed from the patient without sequelae.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Criteria prior to being released for distribution.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.

• Brand Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 18888356
• Report Number: 3015053858-2024-00013
• Device Sequence Number: 20734315
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)250228(10)82272106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 02/28/2025
• Device Model Number: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 82272106
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: 6F PINNCALE SHEATH - TERUMO
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown