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

Model Number	C2PIVL3012
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported detachment was confirmed.The device was returned broken and separated into two pieces.The distal portion of the catheter was missing and not returned.The cause of the reported failures is unknown due to the condition of the returned device.It is possible that the balloon was not fully deflated and therefore made it more difficult to withdraw through the treatment site.Then, the force used to remove the device could have caused it to detach at the distal end, however, it could not be definitively confirmed with the information available.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 c2+ coronary intravascular lithotripsy (ivl) catheter was used to a treat a lesion in the left anterior descending (lad) arteries.The catheter was inserted into the vessel but would not advance past the mid lad due to acute bend and calcification.Ivl was performed with multiple attempts at advancing through the highly calcified segment with minimal movement.Seven cycles were successfully delivered.The physician then advanced the guidezilla guide extension catheter over the shockwave balloon shaft while making multiple attempts to pull it back.After several attempts of repositioning the catheter the physician stated the shaft was no longer connected to the balloon.The shaft had then broken and was removed from the patient, leaving the distal balloon and a portion of the catheter lodged in the lad artery and hanging out into the aortic arch.The wire position in the vessel was lost and multiple unsuccessful attempts were made to recross the lad.The decision was then made to perform cardiovascular (cv) surgery.An impella ventricular assist device was inserted and then the patient was sent to surgery for a bypass and to attempt removal of the remaining portion of the shockwave c2+ catheter.The c2+ balloon encountered resistance and could not be easily withdrawn from the artery.To address this, the surgeon clipped the catheter at the ostium of the lad, securing it distal to the position of the c2+ balloon.The patient is currently stable in the intensive care unit (icu) post-surgery.

• 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: 20588874
• Report Number: 3015053858-2024-00124
• Device Sequence Number: 20474950
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250630(10)02A230516A
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• 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): 11/01/2024

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: 05/31/2025
• Device Model Number: C2PIVL3012
• Device Catalogue Number: C2PIVL3012
• Device Lot Number: 02A230516A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.25MM COMPLIANT BALLOON - UNKNOWN MANUFACTURER; 2.75MM COMPLIANT BALLOON - UNKNOWN MANUFACTURER; GUIDEZILLA GUIDE CATHETER - BOSTON SCIENTIFIC; IMPELLA DEVICE - ABIOMED
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown