MAUDE Adverse Event Report: EMBOLX, INC. SNIPER; BALLOON OCCLUSION CATHETER

Model Number	SBC0629-STR-150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation could not be performed since the hospital has not returned the complaint device.So, at this time, we are unable to determine the exact root cause of this device failure.A review of the approved device history record indicates the lot met all release criteria.Our manufacturing group does conduct 100% inspection on each device and tests them for balloon functionality.Each balloon is inspected to ensure they inflate and deflate properly.Note: this report was delayed in submission due to issues related to user services and confusion on status of acks when initially submitted.
Event or Problem Description
It was reported that, during prostate artery embolization procedure, the device balloon was inflated in 2mm vessel, then embolized with 40-80 embozine to stasis.The balloon would not deflate after several attempts.The dr.Decided to over inflate to burst.The dr.Then pulled back the device and there was intima damage to wall of vessel.The dr.Then embolized proximal to injury with coils to stop flow into intima of vessel wall.

• Brand Name: SNIPER
• Common Device Name: BALLOON OCCLUSION CATHETER
• Manufacturer (Section D): EMBOLX, INC.; 530 lakeside drive, #200; sunnyvale, ca
• MDR Report Key: 10070011
• Report Number: 3011660785-2020-00001
• Device Sequence Number: 10932163
• Product Code: MJN
• UDI-Device Identifier: 00853359008032
• UDI-Public: (01)00853359008032(17)201118(10)EMB11181902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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 Expiration Date: 11/18/2020
• Device Model Number: SBC0629-STR-150
• Device Catalogue Number: SBC0629-STR-150
• Device Lot Number: EMB111819-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR