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

Model Number	M5PIVL7060
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.Based on the reported event, the distal balloon marker broke off and completely separated from the balloon.The balloon had detached and fell inside the patient.The physician opted not to retrieve the balloon but decided to place a stent over the separated piece by trapping it to the vessel wall with it.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.
Event or Problem Description
An m5 plus peripheral intravascular lithotripsy (ivl) catheter was used treat the iliac artery due to occlusive disease/claudication.Access to the lesion was obtained via femoral approach.It was reported that after the m5+ balloon delivered 181 pulses to the target lesion, the physician deflated the balloon, pulled it back towards the lesion and back into the sheath.However, the distal balloon marker broke off completely and the balloon fell inside the patient's anatomy.The balloon is left inside the patient and the physician did not attempt to retrieve it.The physician decided that the best solution was to stent over the separated piece by trapping it to the wall with the stent.There is no plan to remove the balloon since the stent was placed as per the normal treatment.The physician felt it was a difficult procedure that turned out successfully.The patient was discharged to home the same day with no clinical sequelae.

• Brand Name: SHOCKWAVE M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IV) 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
• MDR Report Key: 15728643
• Report Number: 3015053858-2022-00064
• Device Sequence Number: 20645902
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)240430(10)82250532
• 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): 10/31/2022

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: 04/30/2024
• Device Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82250532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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
• Patient Sex: Unknown