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

Model Number	SBC0629-STR-110
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that balloon deflation failure occurred.Evaluation of the unit indicates that the probable cause is the length of the pet extension is greater than specified.The extra length is believed to obstruct the deflation lumen during aggressive deflation vacuum (using large 10 ml syringe).The physician completed the case without any clinical consequences to the patient.Note: this report was delayed in submission due to issues related to user services.
Event or Problem Description
Balloon wouldn't deflate.

• Brand Name: SNIPER
• Common Device Name: BALLOON OCCLUSION CATHETER
• Manufacturer (Section D): EMBOLX, INC.; 530 lakeside dr. #200; sunnyvale, ca
• MDR Report Key: 10029256
• Report Number: 3011660785-2020-00002
• Device Sequence Number: 19490148
• Product Code: MJN
• UDI-Device Identifier: 00853359008056
• UDI-Public: (01)00853359008056(17)201219(10)EMB12191901
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 12/19/2020
• Device Model Number: SBC0629-STR-110
• Device Catalogue Number: SBC0629-STR-110
• Device Lot Number: EMB121919-01
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR