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

Model Number	SBC0629-STR-150
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported per hospital medwatch report #13450705 that the hydrophilic coating on the catheter failed.The catheter was removed and replaced with another of the same with no harm to the patient.
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation, therefore a failure analysis could not be completed.User facility report indicated no patient harm.Communications with physicians at the user facility revealed no knowledge of this occurrence.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: SNIPER
• Common Device Name: BALLOON OCCLUSION CATHETER
• Manufacturer (Section D): EMBOLX, INC.; 530 lakewide dr., suite 200; sunnyvale CA 94085
• Manufacturer (Section G): EMBOLX, INC.; 530 lakeside dr., suite 200; sunnyvale CA 94085
• Manufacturer Contact: jeff pielemeier ; 530 lakeside dr., suite 200; sunnyvale, CA 94085
• MDR Report Key: 14131795
• Report Number: 3011660785-2022-00002
• Device Sequence Number: 14022516
• Product Code: MJN
• UDI-Device Identifier: 00853359008032
• UDI-Public: (01)00853359008032(17)220608(10)EMX06082102
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K180904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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 Expiration Date: 06/08/2022
• Device Model Number: SBC0629-STR-150
• Device Catalogue Number: SBC0629-STR-150
• Device Lot Number: EMX060821-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown