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

Model Number	C2IVL2512
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shockwave c2 coronary intravascular lithotripsy catheter was used to treat a lesion in the #7 branch of the left anterior descending (lad) artery.The lesion was severely calcified (360 degrees, 90% occluded, 10mm long lesion).The patient showed discomfort and his blood pressure decreased to 50 mmhg during pre-dilatation was performed and before the initial insertion of the ivl catheter.The patient's condition and blood pressure recovered when the pre-dilation was completed.Reportedly, after the first balloon inflation at 4 atm, no pulse could be delivered, and error 88 was displayed.The ivl catheter was removed from the patient's body where the physician was able to deliver a pulse outside.The ivl catheter was then reinserted back into the patient and re-inflated.A balloon rupture occurred and the patient experienced ventricular fibrillation (vfib).No drug was used during the procedure before vfib.The patient was transferred to the intensive care unit (icu).As of this date, it is unknown if the patient has been discharged home.According to the rep, the physician believes that the ivl catheter has no relationship to the reported adverse event.The physician thinks that when the ivl catheter delivered a pulse outside the body, air was introduced inside the balloon, which was not fully removed and caused the balloon to rupture.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported failure of balloon loss of pressure was confirmed.Based on the investigation observations, the failure could possibly be attributed to a combination of heat effects and user error because the physician removed the device from the patient's body, pulsed the device outside of the patient's body, and reinserted the device at which time the loss of pressure occurred.Per the ifu (lbl-63927), 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." additionally, the ifu (lbl-63927) states "if the ivl catheter appears not to deliver lithotripsy therapy, remove and replace it with another catheter." it is possible that the balloon was damaged when the device was pulsed outside of the body and the balloon ruptured when reinserted.The reported error 88 failure could not be replicated; no issues were seen when pulsing the device.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.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY
• 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: 17243419
• Report Number: 3015053858-2023-00039
• Device Sequence Number: 12470186
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)250430(10)A230404B
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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: 04/30/2025
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A230404B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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: DRUG-ELUTING STENT (DES) - UNKNOWN MANUFACTURER; RYUREI PTCA DILATION CATHETER - TERUMO; WOLVERINE CUTTING BALLOON - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male