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

Model Number	C2IVL2512
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a shockwave c2 coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion located in the coronary arteries.It was reported that when the physician was attempting to remove the ivl catheter, it got stuck in the lesion.When the physician tried to remove the medtronic 6f telescope guide extension, the shaft of the catheter separated.All attempts to snare the broken piece were unsuccessful.The patient was sent to the operating room (or) to surgically remove the fragment however, the patient expired.No additional information was provided.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.For investigation therefore, inspection of the device could not be performed.Based on the reported event, when attempting to remove the medtronic 6f telescope guide extension, the shaft of the shockwave c2 coronary intravascular lithotripsy (ivl) catheter separated.Snaring was attempted to retrieve the device but was unsuccessful.The patient was sent to the operating room to surgically remove the fragment, however, the patient expired.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.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.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of the balloon becoming stuck and detaching from the catheter was confirmed.The device was received broken and separated into four pieces.All components were present and accounted for, indicating that no fragments were left in the patient.All emitters showed signs of wear indicating that they were fired as expected.No ruptures or tears were noted on the balloon surface.The balloon was found wrinkled, which indicates that it likely became stuck and prevented the device from being removed.The exact cause of the balloon becoming stuck and detaching from the catheter could not be determined.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 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 Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 17492004
• Report Number: 3015053858-2023-00049
• Device Sequence Number: 17955121
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)241130(10)A221128B
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A221128B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: MEDTRONIC 6F EBU 3.5 LAUNCHER - MEDTRONIC.; MEDTRONIC 6F TELESCOPE - MEDTRONIC.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown