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

Model Number	C2IVL4012
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the reported balloon rupture was attributed to a combination of patient calcium and thermal heat affects from the catheter emitters.The root cause for the symptoms the patient reportedly was experiencing could not be determined with the information available, as the patient's pre-existing medical condition is unknown.However, 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.The adverse events of angina and hypotension reported per this case, are known potential adverse effects with standard catheter-based cardiac interventions and are listed in the shockwave c2 ivl instructions for use.
Event or Problem Description
Two shockwave c2 coronary lithotripsy (ivl) devices were used to treat a lesion in the left main coronary artery.Initially, shockwave's c2ivl4012 catheter was prepped and inserted into the patient.It was reported that the device lost pressure after delivering 2 pulses of ivl therapy.Subsequently, a second shockwave catheter was prepped and inserted into the patient (c2ivl3512), and that devise was also reported to have lost pressure after delivering 2 pulses of ivl therapy.Both catheters were inflated to 4 atmospheres at the time of ivl delivery.A non-compliant (nc) balloon was then used following the rupture of the shockwave devices to continue the case.The patient reported to experience symptoms of hypotension and angina, requiring additional pharmacological therapy with norepinephrine.Based on provided information, it is unclear if the symptoms occurred after either the first or second ivl balloon pressure loss.Ivus guided percutaneous coronary intervention was successfully completed on the left main bifurcation without any further complications.Post procedure, the patient was stable with no angina symptoms, with stable blood pressure values.Norepinephrine was no longer necessary.Patient was discharged as planned.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: 12334772
• Report Number: 3015053858-2021-00016
• Device Sequence Number: 5360640
• Product Code: QMG
• UDI-Device Identifier: 00195451000119
• UDI-Public: 0100195451000119
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/19/2021

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: 12/31/2022
• Device Model Number: C2IVL4012
• Device Lot Number: P201207C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C2IVL3512 LOT P201214C SHOCKWAVE MEDICAL; NON-COMPLIANT BALLOON
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR