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

Model Number	C2IVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/11/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent a percutaneous coronary intervention (pci) of the left anterior descending (lad) and circumflex (cx) arteries and the left main (lm) due to heavy calcium as determined by optical coherence tomography (oct) and post orbital atherectomy.Arterial access to the target lesion was obtained via the femoral artery.Orbital atherectomy was performed along with high pressure balloon inflations and the patient's rhythm changed after several inflations and pulse cycles with the shockwave c2 coronary intravascular lithotripsy (ivl) balloon.Reportedly, during the ivl treatment, the patient lost conduction from a left bundle branch block (lbbb) that disrupted the electrical impulse to cause the heart to beat.A temporary pacemaker was inserted, and the procedure continued as planned.It took only a few minutes to insert the pacemaker after the conduction was lost.The pacemaker was not removed after the pci and the patient was transferred to the intensive care unit (icu).It was reported that several days after the procedure, the patient expired of unrelated complications.The physician was adamant that ivl was not the cause of the patient's loss of conduction.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, no investigation can be performed.Based on the complaint description, the patient experienced lost conduction from a left bundle branch block (lbbb) during the ivl treatment.A temporary pacemaker was inserted however, the patient expired several days later.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.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.
Additional Manufacturer Narrative
Per fda's request, shockwave medical, inc.Has corrected the product code from omg to qmg.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• 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 ; 8777754846
• MDR Report Key: 17631989
• Report Number: 3015053858-2023-00050
• Device Sequence Number: 7318857
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)250228(10)A230201F
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2025
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A230201F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: HIGH PRESSURE BALLOONS - UNKNOWN BRAND/ MNFR.; OPTICAL COHERENCE TOMOGRAPHY - UNKNOWN MFR.; PACEMAKER - UNKNOWN BRAND/ MANUFACTURER.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White