MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE PERIPHERAL S4 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER; SHOCKWAVE S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER,

Model Number	S4IVL3040
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Restenosis (4576)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in the btk ii study was not returned therefore, a physical examination could not be performed.Based on the provided information, the patient experienced target lesion revascularization post procedure.Any balloon inflation with ivl or pta causes trauma to the arterial wall resulting in some form of hyperplasia and can cause restenosis and lead to a revascularization.In btk lesions, this is even more pronounced since there are no drug coated balloons approved in these arteries and drug eluting stents are infrequently used.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
This report is being submitted by shockwave medical, inc.Regarding the peripheral s4 intravascular lithotripsy catheter (s4ivl) which was used in a clinical btk ii study.It was reported that a patient presented at the hospital post procedure on (b)(6) 2022.It was found that there was a lesion revascularization in the left anterior tibial artery of the treated left leg.Reportedly, the adverse event has a probable relationship to the device, but it has no relationship to the procedure.The reported adverse event was resolved on (b)(6) 2022 with percutaneous therapy and with a cutting balloon.
Event or Problem Description
Received correspondence from clinical reporting that they reviewed the adverse event (ae) and confirmed the target lesion revascularization occurred, but the ae term was updated to worsening hallux wound.The wound was the reason for the target lesion revascularization.
Additional Manufacturer Narrative
Shockwave medical, inc.Received additional information reporting that the clinical team reviewed the reported adverse event (ae) and confirmed that the reported target lesion revascularization occurred but it was updated to worsening hallux wound.The wound was the reason for the revascularization.

• Brand Name: SHOCKWAVE PERIPHERAL S4 INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE S4 PERIPHERAL 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: 15451349
• Report Number: 3015053858-2022-00057
• Device Sequence Number: 6020667
• Product Code: PPN
• UDI-Device Identifier: 00195451000058
• UDI-Public: (01)00195451000058(17)230531(10)A210519D
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K198140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 05/31/2023
• Device Model Number: S4IVL3040
• Device Catalogue Number: S4IVL3040
• Device Lot Number: A210519D
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: CUTTING BALLOON (UNKINOWN MANUFACTURER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown