MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5+ IVL; PERCUTANEOUS CATHETER, ULTRASOUND

Model Number	M5IVL5560
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Shockwave device ruptured in patient's right leg.Removed from body with no harm to patient.Physician aware, device saved.Fda safety report id# (b)(4).

• Brand Name: SHOCKWAVE M5+ IVL
• Common Device Name: PERCUTANEOUS CATHETER, ULTRASOUND
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.
• MDR Report Key: 15498812
• Report Number: MW5112291
• Device Sequence Number: 19284177
• Product Code: PPN
• UDI-Device Identifier: 00195451000249
• UDI-Public: (01)00195451000249(17)240531(10)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 05/31/2024
• Device Model Number: M5IVL5560
• Device Catalogue Number: M5PIVL5560
• Device Lot Number: A220506D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown