MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	5.0X60MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Tachycardia (2095)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical inc.For investigation therefore, no investigation can be performed.The reporting party did not report a device malfunction.Based on the reported event, after the ivl balloon delivered one cycle of pulse, the patient experienced ventricular tachycardia (v-tach).The physician didn't think it was related to the ivl catheter and so he deflated the balloon and reinflated it to deliver the second cycle.Once the cycle began, the v-tach reappeared.After the physician stopped the ivl treatment, the patient reverted to atrial fibrillation (afib).The afib was treated with intravenous unfractionated heparinization.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.
Event or Problem Description
It was reported that an 84-year-old male patient underwent a left leg intervention to treat a diseased superficial femora artery (sfa).The mid to distal artery was reported to have severe calcium.The vascular surgeon used a diamondback 360¿ coronary orbital atherectomy system to prepare the lesion.It was followed by advancing the shockwave m5plus peripheral intravascular lithotripsy (ivl) catheter in the sfa.At once, the patient experienced baseline rhythm atrial fibrillation (afib).After the ivl catheter delivered one cycle of pulses, the anesthesiologist called out that the patient was in ventricular tachycardia (v-tach).Reportedly, the vascular surgeon didn't think it was related to ivl.The balloon was deflated and reinflated to start the second cycle.Once the second cycle began the v-tach reappeared.The ivl treatment was stopped and after the ivl catheter was removed, the patient reverted to afib within seconds without chemical or electrical cardioversion.Reportedly, the vascular surgeon did not treat the afib except provide intravenous unfractionated heparinization that is used for most cases.The patient was admitted overnight at the hospital and was discharged the following day.

• Brand Name: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH THE SHOCKWAVE M5+
• 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: 18107259
• Report Number: 3015053858-2023-00063
• Device Sequence Number: 7717677
• Product Code: PPN
• UDI-Device Identifier: 00195451000232
• UDI-Public: (01)00195451000232(17)241130(10)82269328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203365
• 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): 05/19/2025

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: 11/30/2024
• Device Model Number: 5.0X60MM
• Device Catalogue Number: M5PIVL5060
• Device Lot Number: 82269328
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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: DIAMONDBACK 360¿ CORONARY ORBITAL ATHERECTOMY SYST
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male