MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P.; SURGIFOAM SIZE 50 (1973)

Model Number	1973
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	11/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The patient has developed a stroke.No further information is available as to when the patient developed the stroke, type of surgery or how the surgifoam¿ sponge was used during surgery.At this point of time due to lack of information it cannot be assessed if surgifoam¿ sponge is a contributory factor in the development of the patient's stroke.Therefore, additional clinical questions have been asked.For evaluation on this event please refer to attached letter (from 2018).File attachments.This report is a repeat of mfr report # 3008478369-2018-00003 since the original mfr report was inadvertently overwritten by the importer for reporting a separate incident.
Event or Problem Description
It was reported that the patient underwent an unknown procedure and surgifoam was used.A piece of the surgifoam became lodged and moved through the patient's internal mammary artery near the sternum, then into the vertebral and sublclavian arteries causing the basilar artery occlusion and the patient to have a stroke.A cta of the neck and brain showed the rva occlusion.Ferrosan medical devices (b)(4) reference no.: (b)(4).This event was originally reported as 3008478369-2018-00003.However, a maude search showed that this report number was inadvertently overwritten by the importer.

• Brand Name: SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P.
• Common Device Name: SURGIFOAM SIZE 50 (1973)
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 11086468
• Report Number: 3008478369-2020-00032
• Device Sequence Number: 2688404
• Product Code: LMF
• UDI-Device Identifier: 15712123000172
• UDI-Public: 15712123000172
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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: 07/11/2022
• Device Model Number: 1973
• Device Lot Number: 254257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 12/29/2020
• 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: Death
• Patient Age: 87 YR