MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5PIVL6060
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a procedure to treat a heavily calcified distal superficial femoral artery (sfa) and popliteal artery.Access was obtained via the femoral artery.After the shockwave m5plus peripheral intravascular lithotripsy (ivl) balloon successfully delivered 30 pulses, the physician attempted to deflate the balloon with an indeflator.However, it was observed on angiogram that contrast was still present in the balloon after multiple negative pulls.The physician ended up deflating the balloon with a large syringe.The balloon was repositioned slightly to the proximal lesion and was inflated again.Another round of treatment was given and again, balloon deflation proved difficult, so the physician attempted to remove the ivl catheter over the 0.014" guidewire.It was observed on an angiogram that a complete separation of the distal balloon marker and the distal emitter occurred, so the catheter was pulled back with extreme caution.Once the catheter had been removed entirely from the patient's body, there was great difficulty removing it from the end of the 0.014" wire.The physician cut through a portion of the body of the catheter once the proximal end of the catheter had been advanced over the end of the guidewire to adequately pull on the remainder of the catheter that would not come off of the end of the guidewire.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported failure of unable to deflate could not be definitively confirmed as the device was returned in three separate pieces.Based on the reported information, the balloon may not have been fully deflated during removal.It is likely that it got caught by the sheath and force was used to withdraw the device, which caused it to separate.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.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.

• Brand Name: SHOCKWAVE M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) 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 ; 8777754846
• MDR Report Key: 17760924
• Report Number: 3015053858-2023-00051
• Device Sequence Number: 6654638
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)241130(10)82269334
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/31/2023

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: 11/30/2024
• Device Model Number: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 82269334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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: 0.014" GUIDEWIRE - UNKNOWN MANUFACTURER
• Patient Sex: Unknown