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

Model Number	M5PIVL7060
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion located in the common femoral artery (cfa).The first ivl balloon ruptured after 3 cycles so a second ivl balloon was prepped and used.The balloon successfully delivered all 300 pulses in the cfa and then the balloon was repositioned in the superficial femoral artery (sfa) to deliver an additional 75 pulses.During post dilatation, the balloon ruptured and when the physician was removing the catheter, difficulties removing the catheter though a 6f sheath was encountered.Once the catheter was outside the patient's anatomy, it was observed that the distal 20-30mm of the balloon material was missing.Reportedly, the physician was unable to locate the missing piece of the balloon and it is believed it was left in the patient's anatomy.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical inc., therefore, a physical examination could not 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 subject device was returned for investigation and inspected.The device was returned with half of the balloon missing.Balloon missing piece was unable to be retrieved during a surgical repair of the cfa, therefore, a physical examination of the other half could not be performed.The reported failure was confirmed.Based on the description of the event, the m5+ ivl device was being removed through the 6f sheath, it is possible that the balloon ruptured, and it could not be fully deflated.Then was caught onto something and with force was used to withdraw the device that caused it to separate.It was noted that the device was initially used 75 pulses and the physician observed the balloon and noticed 20-30mm of the balloon material was missing and left within the patient.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.

• 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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara 95054
• MDR Report Key: 17110822
• Report Number: 3015053858-2023-00036
• Device Sequence Number: 11306199
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)240831(10)82260390
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 08/31/2024
• Device Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82260390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH (UNKNOWN MANUFACTURER).
• Patient Sex: Unknown