MAUDE Adverse Event Report: BALT USA, LLC BALLAST LONG SHEATH

Model Number	BALLAST90
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Embolus (1830)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report.Device not sent back to manufacturer.Reaching out with physician for additional information to help an investigation.
Event or Problem Description
It was reported that: "first time use of ballast 90 in an avm patient.Dr.(b)(6) accessed the right internal carotid but couldn't get the ballast to move into the horizontal petrous segment over a.035 exchange wire.He then accessed the left internal carotid with a.038 glide wire and again the ballast would not track into the horizontal petrous section.He also tried to advance of the scepter balloon 4x11 and it still wouldn't move into the horizontal petrous section.That evening the patient experienced diffuse showering of emboli in both hemispheres".
Additional Manufacturer Narrative
Initial report.Device not sent back to manufacturer.With being unable to reach out to the physician the complaint will route to close with being unable to determine route cause.However, upon further review based on the data presented it seems curious that a balloon as small as a scepter would not traverse the petrous segment.This suggest something is anatomically out of the ordinary.Ballast has not been confirmed the cause of the diffuse showering of emboli, and the team is thinking that possibly there was a preexisting known disease.It also should be noted that ballast is designed as a carotid sheath for support of ancillary devices.It is not designed for distal access.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "first time use of ballast 90 in an avm patient.Dr.(b)(6) accessed the right internal carotid but couldn't get the ballast to move into the horizontal petrous segment over a.035 exchange wire.He then accessed the left internal carotid with a.038 glide wire and again the ballast would not track into the horizontal petrous section.He also tried to advance of the scepter balloon 4x11 and it still wouldn't move into the horizontal petrous section.That evening the patient experienced diffuse showering of emboli in both hemispheres.".

• Brand Name: BALLAST LONG SHEATH
• Common Device Name: BALLAST
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8634466
• Report Number: 3014162263-2019-00005
• Device Sequence Number: 19297144
• Product Code: DQY
• UDI-Device Identifier: 00818053022890
• UDI-Public: 00818053022890
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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 Expiration Date: 12/05/2019
• Device Model Number: BALLAST90
• Device Lot Number: 120518I
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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: Life Threatening