MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT; WOUND CLEANSER

Model Number	403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seizures (2063); Transient Ischemic Attack (2109)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr § 803.This report is based upon information provided to irrimax.Irrimax will continue to contact reporting physician and other sources as necessary for the purpose of obtaining additional information and will, as necessary, file a follow-up report.
Event or Problem Description
Physician reported that the use of irrisept during an indirect biopsy possibly could have caused seizure(s) and/or stroke(s) in a patient with moyamoya disease.According to nih, moyamoya disease is a progressive, occlusive disease of the cerebral vasculature involving the carotid artery in the skull.Moyamoya may cause transient ischemic attacks, strokes, aneurysms or bleeding in the brain.Physician reported that the use of irrisept during the indirect biopsy of the patient with moyamoya disease and the seizure(s) and/or stroke(s) were likely not linked.
Additional Manufacturer Narrative
Irrimax is submitting this follow-up report in accordance with 21 cfr § 803.This report is based upon information provided to irrimax.Irrimax evaluated lot numbers (006k088, 6j054, 6j010, or 6f103) that could include the device used.No failure was detected.The previous paragraph shall be included in any information or report disclosed to the public including information or reports under the freedom of information act.
Event or Problem Description
Physician reported that the use of irrisept during an indirect biopsy possibly could have caused seizure(s) and/or stroke(s) in a patient with moyamoya disease.According to nih, moyamoya disease is a progressive, occlusive disease of the cerebral vasculature involving the carotid artery in the skull.Moyamoya may cause transient ischemic attacks, strokes, aneurysms or bleeding in the brain.Physician reported that the use of irrisept during the indirect biopsy of the patient with moyamoya disease and the seizure(s) and/or stroke(s) were likely not linked.

• Brand Name: IRRISEPT
• Common Device Name: WOUND CLEANSER
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway; suite 102; lawrenceville GA 30043
• MDR Report Key: 6730321
• Report Number: 3005706359-2017-00001
• Device Sequence Number: 13795797
• Product Code: FQH
• UDI-Device Identifier: 10842351100032
• UDI-Public: 10842351100032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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 Model Number: 403
• Device Catalogue Number: IRRISEPT-403
• Device Lot Number: SEE SECTION 10 BELOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: Hospitalization; Other
• Patient Age: 52 YR
• Patient Weight: 59