MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5; PERCUTANEOUS CATHETER, ULTRASOUND

Model Number	7.0 X 60MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Shockwave balloon ruptured and dislodged in the r(ight) common iliac after inflation.Physician deployed stent and pushed balloon against wall of vessel.Physician note: we want to do our final shockwave therapy at the aortoiliac bifurcation at the completion of all the therapies delivered, and as we were done, the balloon ruptured.The maximum balloon dilatation throughout the procedure was 8 atmospheres.We therefore proceeded to extract the shockwave balloon, and upon withdrawal we noted that the distal half of the balloon remained within the body at the level of the right common iliac artery on our wire.We then proceeded to advance our self-expanding stent epic 12 x 60 that extended from the ostium of the right common iliac artery to the very proximal right external iliac artery.This entrapped the segment of the balloon that was left in the common iliac artery.Remnants of the shockwave balloon were trapped outside the deployed stent in the common iliac artery (black dot noted).The patient was told a remnant of the shockwave balloon was left in his body but securing and crushed outside a stent in the right common iliac artery.No harm to patient.

• Brand Name: SHOCKWAVE M5
• Common Device Name: PERCUTANEOUS CATHETER, ULTRASOUND
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 13577102
• Report Number: 13577102
• Device Sequence Number: 4410314
• Product Code: PPN
• UDI-Device Identifier: 00195451000195
• UDI-Public: (01)00195451000195(17)230531(10)A210519B
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2022
• Report Date (Section F): 02/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7.0 X 60MM
• Device Catalogue Number: M5IVL7060
• Device Lot Number: A210519B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White
• Date Report Sent to FDA: 02/14/2022