MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1952
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumonia (2011); Pneumothorax (2012)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Please clarify if the source of the complaint is from a literature article.If so, please provide the associated article.2.What are the name and date of index surgical procedure? 3.What were the diagnosis and indication for the index surgical procedure? 4.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.5.Confirm if the surgicel product code used in this case is (b)(4).6.What is the lot number? 7.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 8.Where was the surgicel used (on what tissue)? 9.How much surgicel was used during the procedure? 10.Was the surgicel product left in place? was the excess removed? 11.What were current symptoms following the index surgical procedure? onset date? 12.Has any surgical or medical intervention been performed? 13.What is physician¿s opinion as to the cause of or contributing factors to this event? 14.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative experience? 15.What is the users experience w/ surgicel and other hemostatic agents? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.The 69 year old, male patient was diagnosed with pleuroparenchymal fibroelastosis (ppfe) and was treated with home oxygen therapy.The patient developed bilateral mild pneumothorax and was followed up, but the left pneumothorax progressed.After thoracic drainage, pleurodesis using autologous blood was performed six times, but without success.After placing a drain on the right side, thoracoscopically assisted pulmonary fistula closure was performed for the left pneumothorax.A pulmonary cyst was found at the apex of the left upper lobe of the lung, and it was judged that it would be difficult to dissect it with an automatic suturing device, so the base of the thickened pulmonary cyst was ligated using silk thread.After cleaning the thoracic cavity, an oxidized cellulose sheet was pasted around the ligated area, and fibrin glue was applied to complete the surgery.To prevent acute exacerbation of interstitial pneumonia (ip), we devised a surgical technique and performed lung protective ventilation.There were no postoperative complications, and the patient was discharged from the hospital on the 9th postoperative day.On the 7th day after discharge, recurrence of right pneumothorax was observed.Although the degree of collapse was moderate, the patient did not wish to undergo invasive treatment and was treated at home with house calls.Five months after surgery passed without any recurrence of left pneumothorax.Five months after the operation, the patient developed aspiration pneumonia and was admitted to the hospital.The patient showed improvement with antibiotic treatment and was discharged, but on the 10th day after discharge, he became sleepy at home and died permanently.As ppfe progresses, multiple pulmonary cysts form in the upper lobes, and pneumothorax occurs at a high rate.The perioperative mortality rate is also high.This case was a high-risk case with advanced ppfe with fibrosis in the lower lobe as well as findings of right heart overload and contralateral pneumothorax.Additional information was requested.

• Brand Name: SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18653438
• Report Number: 2210968-2024-01012
• Device Sequence Number: 18169605
• Product Code: LMG
• UDI-Device Identifier: 20705031003023
• UDI-Public: 10705031003026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male