MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST; SYRINGE, BALLOON INFLATION

Model Number	AC2205P
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
During a procedure an attempt was made to use one everest inflation device.It was reported that a manometer issue occurred and there was a problem with the inflation device.It was stated that when passing more than one guide wire, there was difficulty with occlusion of the device, which resulted in excess blood loss, as well as injected contrast.There was concerns that this higher-than-expected blood loss could harm the patient's recovery.No further patient injury was reported.
Additional Manufacturer Narrative
Product analysis summary: analysis of the returned device revealed there was no damage to the device.The needle was at approx.0atm on return.Water was aspirated into and purged from the device with no evidence of a blockage/occlusion.Using the in-house stopcock, the device was pressurized with water.The gauge needle moved steadily to 20 atm and the device held pressure for a minimum of three minutes (with max 10% loss), meeting specification, and with no evidence of a leak.Upon release of pressure the gauge needle dropped to approx.0atm.When vacuum was applied, the gauge needle moved into/towards the red ¿vac¿ reading.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: annex d code added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVEREST
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19718306
• Report Number: 1220452-2024-00037
• Device Sequence Number: 8147478
• Product Code: MAV
• UDI-Device Identifier: 00643169843028
• UDI-Public: 00643169843028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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?: Yes
• Device Expiration Date: 11/02/2024
• Device Model Number: AC2205P
• Device Catalogue Number: AC2205P
• Device Lot Number: 60410023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 09/25/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/13/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male