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

Model Number	M5IVL6060
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave m5 peripheral lithotripsy (ivl) device was used to treat a superficial femoral artery (sfa).The ivl catheter completed all 300 pulses without incident.The physician decided to go back to post-dilate the proximal popliteal to proximal sfa with the same ivl balloon at 8atm, which is outside the instructions for use for the m5 device.During the final inflation, a balloon loss of pressure occurred.Upon attempted removal of the ivl catheter, the balloon portion was found to be detached from the ivl catheter.Angiogram was used to locate the detached balloon in the proximal sfa.The physician elected to perform a surgical cutdown of the sfa to retrieve the detached balloon, and all detached components were successfully removed from the patient.The physician believes that a sharp piece of calcium in the proximal sfa may have caused the balloon loss of pressure and subsequent detached component.To date, no patient sequelae has been reported.
Additional Manufacturer Narrative
Based on an investigation of the returned device, the balloon and the distal portion of the catheter were not received for investigation.The balloon tore over the proximal marker band.The event details indicate that the device was inflated to 8 atm.The ifu contains a note that 4 atm is the lithotripsy treatment balloon pressure & 6 atm is nominal balloon pressure and post-treatment angioplasty pressure.Per the event details, all detached components were successfully removed from the patient via surgical cutdown.The reported failure was confirmed.Based on the investigation observations and additional information received from the reporting party, the balloon loss of pressure and subsequent detachment of balloon components could possibly be attributed to post-dilatation of the vessel at 8 atm in the presence of calcium, exceeding the specified inflation pressure of 6 atm in the device instructions for use.The balloon likely tore due to the patient calcium during retraction of the guide catheter.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.
Event or Problem Description
A shockwave m5 peripheral lithotripsy (ivl) device was used to treat a superficial femoral artery (sfa).The ivl catheter completed all 300 pulses without incident.The physician decided to go back to post-dilate the proximal popliteal to proximal sfa with the same ivl balloon at 8atm, which is outside the instructions for use for the m5 device.During the final inflation, a balloon loss of pressure occurred.Upon attempted removal of the ivl catheter, the balloon portion was found to be detached from the ivl catheter.Angiogram was used to locate the detached balloon in the proximal sfa.The physician elected to perform a surgical cutdown of the sfa to retrieve the detached balloon, and all detached components were successfully removed from the patient.The physician believes that a sharp piece of calcium in the proximal sfa may have caused the balloon loss of pressure and subsequent detached component.To date, no patient sequelae has been reported.
Additional Manufacturer Narrative
Based on an investigation of the returned device, the balloon and the distal portion of the catheter were not received for investigation.The balloon tore over the proximal marker band.The event details indicate that the device was inflated to 8 atm.The ifu contains a note that 4 atm is the lithotripsy treatment balloon pressure & 6 atm is nominal balloon pressure and post-treatment angioplasty pressure.Per the event details, all detached components were successfully removed from the patient via surgical cutdown.The reported failure was confirmed.Based on the investigation observations and additional information received from the reporting party, the balloon loss of pressure and subsequent detachment of balloon components could possibly be attributed to post-dilatation of the vessel at 8 atm in the presence of calcium, exceeding the specified inflation pressure of 6 atm in the device instructions for use.The balloon likely tore due to the patient calcium during retraction of the guide catheter.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 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: 13029364
• Report Number: 3015053858-2021-00034
• Device Sequence Number: 14556868
• Product Code: PPN
• UDI-Device Identifier: M732M5IVL60600
• UDI-Public: +M732M5IVL60600/$$3221130P201120BC
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• 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): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: M5IVL6060
• Device Catalogue Number: M5IVL6060
• Device Lot Number: P201120B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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: AVANTI SHEATH; BOSTON BALLOON AND STENT; COMMAND WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male