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

Model Number	M5PIVL6060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the detached balloon and shaft could not be definitively determined based on the reported information, 6fr slender sheath was kinked secondary to the patient bending their leg at the access site, and the ivl device became caught on the kink in the sheath upon attempts to remove the ivl catheter, requiring force and subsequent damage and detachment of the device.However, this cannot be definitively confirmed without a review of the device.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 plus intravascular lithotripsy (ivl) catheter was used to treat a lesion in the superficial femoral arteries (sfa).The catheter was introduced into the body with no resistance and successfully delivered 300 pulses.During withdrawal, it was noted that the 6fr terumo slender sheath became severely kinked secondary to the patient bending their leg at the popliteal access site, causing the ivl catheter to get stuck inside the sheath.The physician then pulled the catheter with force, causing the catheter shaft to detach from the balloon during removal from the sheath, leaving the detached balloon partially in the sheath.It was confirmed that the detached components were contained in the sheath.The sheath and balloon were then exchanged for a new 6fr slender sheath.There was no patient harm reported.

• 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: 20150168
• Report Number: 3015053858-2024-00100
• Device Sequence Number: 8369361
• Product Code: PPN
• UDI-Device Identifier: 00195451000256
• UDI-Public: (01)00195451000256(17)250331(10)82277281
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/05/2024

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: M5PIVL6060
• Device Catalogue Number: M5PIVL6060
• Device Lot Number: 82277281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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: 0.014 SPARTACORE GUIDEWIRE - ABBOTT; 6FR SLENDER SHEATH - TERUMO; BALLOON DILATION CATHETER - BOSTON SCIENTIFIC; DRUG-COATED BALLOON (DCB) - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male