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

Model Number	2.5 X 12MM
Medical Device Problem Codes	Partial Blockage (1065); Material Rupture (1546)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.During the investigation, it was found that the emitters showed signs of wear, indicating that they were fired as expected.The reported balloon loss of pressure was confirmed as a pinhole was noted over emitter # 1.Based on the reported event, thrombosis was observed at the site where the covered stent was implanted.The thrombosis was perfused with multiple inflations using balloon catheter and placement of drug-eluting stent (des).The cause of the thrombosis could not be definitively determined.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 during a procedure using a shockwave c2 coronary intravascular (ivl) catheter in the # 7 branch of the left anterior descending artery (lad), the ivl balloon delivered 10 pulses.During the 2nd cycle, the balloon delivered 7 pulses.However, the balloon was fluoroscopically observed that the pressure was decreasing, and the balloon was simultaneously diminishing in size.During imaging, a leakage from the same target vessel (lad) was noted under fluoroscopy so the physician immediately placed a papyrus covered stent to tamponade the leak.Post ivl treatment, full and patent hemostasis was achieved.Then the physician treated the distal to proximal lesion in the #6 branch of the lad.During the use of the ivl catheter, it was observed that there was a slow flow and thrombosis was noted at the site of the papyrus stent that was placed in the #7 branch.It was also noted that the proximal part of the stent was not a precise circle.The physician aspirated the thrombus and performed long inflations using a perfusion balloon catheter.Then a biofreedom drug-coated coronary stent (des) was implanted in the #6 branch.The intended procedure was completed with no additional interventions.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY 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 ; 8777754846
• MDR Report Key: 17871176
• Report Number: 3015053858-2023-00059
• Device Sequence Number: 17516235
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)250531(10)09A230531A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 05/31/2025
• Device Model Number: 2.5 X 12MM
• Device Catalogue Number: C2IVL2512
• Device Lot Number: 09A230531A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: BIOFREEDOM DES - BIOSENSORS; PAPYRUS COVERED STENT - BIOTRONIK; PERFUSION BALLOON CATHETER - UNKNOWN MFR
• Patient Age: 79 YR
• Patient Sex: Male