MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE S4 PERIPHERAL IVL CATHETER; BALLOON CATHETER

Model Number	61163-3540
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Ischemic Heart Disease (2493); Vascular Dissection (3160)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device was not returned by the reporting party.Therefore, inspection of the device could not be performed.The cause of the failure is unknown, but review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all acceptance criteria prior to shipping.It is noted from the reported information that the device was used successfully to deliver ~20 pulses.According to the physician, during delivery of therapy to the left anterior descending (lad) coronary artery, the vessel dissected into the lad, left main and into the aorta.The physician noted the patient was alert and stable the entire time and that a dissection would have occurred with any device since the lad was so severely calcified.The physician treated the dissection with stents in the lad and left main.The patient experienced post procedure chest pain, an ekg was normal, and the ct revealed an intramural hematoma in the aorta that was treated conservatively with medical management.The patient was discharged from the hospital after 7 days and the plan was to see the patient in the office in a few weeks.The physician expects a full recovery of the patient.
Event or Problem Description
A shockwave representative was made aware of an off-label case by the physician where a peripheral catheter was used in a coronary case.The physician understood the procedure was off label and determined it was the only treatment option for the patient.The physician was treating the lad and indicated a balloon rupture during ivl treatment after approximately twenty pulses.According to the physician, during delivery of therapy to the left anterior descending (lad) coronary artery, the vessel dissected into the lad, left main and into the aorta.The physician noted the patient was alert and stable the entire time and that a dissection would have occurred with any device since the lad was so severely calcified.The physician treated the dissection with stents in the lad and left main.The patient experienced post procedure chest pain, an ekg was normal, and the ct revealed an intramural hematoma in the aorta that was treated conservatively with medical management.The patient was discharged from the hospital after 7 days and the plan was to see the patient in the office in a few weeks.The physician expects a full recovery of the patient.

• Brand Name: SHOCKWAVE S4 PERIPHERAL IVL CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 48501 warm springs blvd.; suite 108; fremont CA 94539
• MDR Report Key: 8697738
• Report Number: 3010940016-2019-00002
• Device Sequence Number: 1831482
• Product Code: PPN
• UDI-Device Identifier: M732S4IVL35400
• UDI-Public: M732S4IVL35400
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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: 01/31/2021
• Device Model Number: 61163-3540
• Device Catalogue Number: S4IVL3540
• Device Lot Number: P190108C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention