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 Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on a review of the returned device, the reported failure was confirmed.The device was received with a portion of the balloon catheter missing.Based on the description of the event, a portion of the device remained inside the patient.All other aspects of the device remained intact, with no other signs of physical damage on the balloon.It was reported that the physician encountered difficulties attempting to cross the lesion, including attempting to open the lad lesion using a non-compliant (nc) balloon without success.It is possible that anatomical factors contributed to the difficulties to remove and subsequent detachment of the balloon catheter components; however, this cannot be definitively confirmed without a review of the intraoperative imaging.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.
Event or Problem Description
A shockwave c2 coronary lithotripsy (ivl) device was successfully used to treat a lesion in the left anterior descending (lad) artery.The physician attempted to open the lad lesion using a non-compliant (nc) balloon without success.The c2 catheter was prepped and inserted into the patient.Following balloon inflation and initiation of ivl, the balloon lost pressure after 3 pulses.The balloon was deflated and attempts to remove the balloon were unsuccessful, leaving a portion of the balloon jailed against the vessel wall.Half of balloon remained attached on the vessel wall, and the physician was unable to recross the lesion with the guidewire and elected to convert the patient to surgical bypass.There have been no additional patient sequelae reported.

• 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
• MDR Report Key: 12161041
• Report Number: 3015053858-2021-00015
• Device Sequence Number: 3820468
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: 0100195451000089
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 01/31/2023
• Device Model Number: C2IVL2512
• Device Lot Number: P210120I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention