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

Model Number	M5PIVL8060
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of balloon loss of pressure was confirmed.None of the components were left inside of the patient based on the reported information and investigation observations.Further investigation could not be performed because the proximal portion of the catheter was not returned.Per the reported information, it was noted that the device pulsed and went to 10 atm which could have contributed to the rupture.Per the ifu, it is noted that: "4 atm is lithotripsy treatment balloon pressure, 6 atm is nominal balloon pressure and post-treatment angioplasty pressure, and 10 atm is rbp (rated burst pressure) of the balloon".The physician was advised that the nominal pressure was 6 atm and the treatment pressure was 4 atm.It is unknown why the balloon was expanded to 10 atm.Balloon ruptures are a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The patient was noted to have a severely calcified rca.The relationship between the ivl balloon rupture and the reported perforation could not be determined with the information available.This is a known inherent risk with the procedure and the use of the device.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.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 intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac arteries.The ivl catheter delivered 247 pulses.After delivering the desired pulses, the physician inflated the balloon up to the rated burst pressure (rbp) of 10 atm and the balloon ruptured.The physician was advised that the nominal pressure was 6 atm and the treatment pressure was 4 atm.It is unknown why the balloon was expanded to 10 atm.When the balloon ruptured, the physician pulled the balloon back before pulling negative on the indeflator.Resistance was noted when pulling back the device into the sheath.The physician then advanced it forward and pulled negative on the balloon.When the physician tried to remove the balloon from the body, it was not moving through the sheath.The balloon then had to be removed with the entire sheath and out in a new one.The patient was unharmed, a significant amount of time was added to the case because they had to snare the wire into the other sheath in order to get a new wire up and successfully remove the sheath to get the balloon out.The procedure was completed by cutting the shockwave catheter close to the sheath entrance, removing the sheath, and then removing the balloon from the body over the wire.There were no fragments of the device left inside the body.A stent was placed after ivl and there no was reported patient harm.

• 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: 20050447
• Report Number: 3015053858-2024-00096
• Device Sequence Number: 18131511
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)250331(10)82279903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/23/2024

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: 03/31/2025
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 82279903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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: .014 GUIDEWIRE - UNKNOWN MANUFACTURER.; 7F SHEATH - UNKNOWN MANUFACTURER.; VBX STENT - GORE MEDICAL.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown