MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2PIVL4012
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	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing and results are not yet available.
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary artery.It was noted that 10 pulses were delivered at an unknown pressure.It was reported that during the procedure, there was a complete separation of the ivl catheter, which remained inside the patient when it detached.It is unknown whether the device was successfully prepped or if the balloon was fully deflated before attempting removal from the sheath.Although the procedure was completed, the ivl procedure was not successful.The patient remained hospitalized before the patient was brought back to the lab two days later for a second procedure to retrieve the remaining catheter.Approximately 28 cm of the distal catheter was snared and removed from the ascending aorta.The location of the detachment relative to the blue strain relief is unknown.Once the catheter was removed, no further intervention was necessary.It is also unclear whether balloon angioplasty was performed.The physician could not provide a reasonable explanation for the balloon detaching from the catheter.The patient has since recovered from the procedure, with no additional adverse events reported.
Additional Manufacturer Narrative
The device was returned to shockwave medical for investigation.The device arrived broken and separated, indicating a significant failure in its structural integrity.The balloon's wrinkles and the break in the outer shaft suggest that the device might have gotten stuck during the procedure.Applying force to remove it could have caused the separation and damage.Additionally, the balloon rupture might have been attributed to patient calcium.It was reported that the device was used at 8 atm, which is higher than the recommended lithotripsy treatment balloon pressure.Per the instructions for use (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".Using the device off-label can increase the risk of failure and complications.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.
Additional Manufacturer Narrative
The device was returned to shockwave medical for investigation and the reported issue was confirmed.The investigation was limited as the proximal portion of the catheter was not returned.It was reported that the ivl balloon was used within a pre-existing stent, which is off-label per the device instructions for use.The ifu only indicates the device for use in de novo lesions.The off-label use (inflation of the balloon within the pre-existing stent) in combination with patient calcium likely resulted in damage to the balloon and subsequent balloon loss of pressure.Using the device off-label can increase the risk of failure and complications.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.Fu1 for mfr# was inadvertantly submitted and acknowledged under patient identifier cp-(b)(6) but should have been fu#1 for mfr# 3015053858-2025-00002.This report is being referenced as fu2 for successful submission and receipt, a correction report will also be submitted for mfr# 3015053858-2025-00002.

• Brand Name: SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2+ CORONARY 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: 21236086
• Report Number: 3015053858-2025-00010
• Device Sequence Number: 13056161
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)260131(10)09A240102A
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S00
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2025

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: 01/31/2024
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 09A240102A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/22/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/03/2025; 02/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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
• Patient Sex: Unknown