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

Model Number	60109-3560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peripheral Vascular Disease (2002)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Shockwave medical was made aware of an incident potentially involving one of the company's marketed ivl devices through a social media posting on (b)(6) 2019.The twitter posting indicated that a vessel had ruptured during the lithotripsy procedure while treating the anterior tibial artery.According to the post, the procedure was done in accordance with the ifu.No atherectomy or previous balloon angioplasty was performed.The rupture was treated with a viabahn covered stent to seal the affected area.Final fluoroscopy images showed that the rupture was successfully covered.Follow up information from the physician indicated that the dissection was most likely due to balloon expansion, and not as a result of the ivl therapy.Per last communication, the physician indicated that the patient was doing fine.Additional case details are limited, and despite the multiple attempts by the company to obtain further case and patient information, very little was provided.Therefore, shockwave is submitting this reportable event out of abundance of caution.

• Brand Name: IVL PERIPHERAL BALLOON DILATATION CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 8755895
• Report Number: 3010940016-2019-00003
• Device Sequence Number: 1708297
• Product Code: PPN
• UDI-Device Identifier: M732LPBC3560DX1
• UDI-Public: M732LPBC3560DX1
• Combination Product (Y/N): N
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 60109-3560
• Device Catalogue Number: M5IVL3560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• 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: Required Intervention