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

Model Number 4.0 X 12MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Electric Shock (2554); Vascular Dissection (3160)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Md went to use 4.0x12 shockwave catheter (lot a210506h) in the left main/lad of patient.When the balloon was in the body, they pulsed the balloon and the port outside of the body lit up.Md then pulled the shockwave catheter out of the body and did an out of the body test.At that point, it lit up again and the doctor was shocked by the device.Doctor then went up with intravenous ultrasound and saw a large dissection in the left main.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Type of Device: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 12982856
• MDR Text Key: 282107578
• Report Number: 12982856
• Device Sequence Number: 1
• Product Code: QMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.0 X 12MM
• Device Catalogue Number: C2IVL4012
• Device Lot Number: A210506H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 82 KG