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

Model Number	M5PIVL8060
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac artery.The physician successfully treated the left iliac artery with 150 pulses.The device was removed from the sheath and reintroduced through the second sheath on the patient's right side, and 150 pulses were delivered in the right iliac artery.Following ivl treatment, the ivl balloon was unable to deflate completely, remaining partially inflated in the patient's iliac.The physician was not able to remove the device through the sheath, therefore, the introducer sheath and ivl catheter had to be removed together.All device components were successfully removed from the patient.Due to risk for enlargement of the initial puncture point in the femoral following removal of the ivl catheter, an 11f introducer was placed for femoral sealing and continuation of the initial procedure.At the end of the procedure, it was necessary to apply proglides and a safeguard dressing due to the increased risk of bleeding.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The device was returned within the introducer sheath and guidewire.All emitters showed signs of wear, indicating that they were fired as expected.The reported failure was confirmed.The device could not be removed from the sheath due to the balloon not being fully deflated.The complaint description states that the ivl catheter was removed from the patient and re-inserted through another introducer sheath on the patient's right side, which is off-label per the device instructions for use.Per the instructions for use, it cautions: "ivl catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy treatments.Balloon can be damaged in the process".It was reported that the ivl balloon was able to be successfully removed from the first introducer sheath following initial ivl treatment.It is possible that the device may have been damaged from the additional device insertion, resulting in the inability to remove 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.

• 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: 19607022
• Report Number: 3015053858-2024-00060
• Device Sequence Number: 6359628
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)250531(10)09A231020A
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/25/2024

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: 05/31/2025
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 09A231020A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: INTRODUCER SHEATH - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male