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

Model Number	C2IVL2512
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Codes	Arrhythmia (1721); Ventricular Fibrillation (2130)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported failure (err88) could not be replicated; however, balloon rupture was confirmed.It is noted that this device was used to deliver pulses within a stent, which could have contributed to the balloon rupture.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.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.
Event or Problem Description
A shockwave c2 coronary intravascular lithotripsy (ivl) balloon was used in a patient who underwent a percutaneous coronary intervention (pci) to treat a chronic under-expanded stent with concentric calcium in the mid left anterior descending (lad) artery.The lesion was pre-dilated with a percutaneous transluminal coronary angioplasty (ptca) non-compliant (nc) balloon.Access to the target lesion was obtained via femoral approach.When the ivl catheter was connected to the generator, the balloon was pressurized to 4 atms and with the 1st push of the button on the connector cable, error 88 was displayed.After the staff cleared the error, the balloon was able to deliver a full 20 pulses before it ruptured.Immediately, the patient experienced ventricular fibrillation (vfib).The patient was "shocked" or defibrillated with a defibrillator and the patient was converted back to intrinsic normal sinus rhythm (nsr).After the patient was defibrillated, no other intervention was needed to treat the vfib.The patient was discharged to home the following day with no clinical sequelae.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: 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: 15451724
• Report Number: 3015053858-2022-00058
• Device Sequence Number: 5582001
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)230731(10)A210720K
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A210720K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: DEFIBRILLATOR (UNKNOWN MANUFACTURER); PTCA BALLOON CATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White