MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Citation: acta cytol.2022 jul 27;1-4.Doi: 10.1159/000525857.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 Description

It was reported via a journal article: title: oxidized regenerated cellulose (surgicel®) on cytology/histology authors: elizabeth m kurian, et al.Citation: acta cytol.2022 jul 27;1-4.Doi: 10.1159/000525857.In patients with a history of malignancy, follow-up surveillance of lymph nodes is required to evaluate for potential malignancy or infection.In some cases, the lymphadenopathy may be secondary to an intraprocedural hemostatic agent and/or related granulomatous reaction.This study presents a case of an 80-year-old female patient with a remote past medical history of breast cancer status post-lumpectomy and chemoradiation.Twenty years later, a 2.4 cm pulmonary right middle lobe nodule was noted on imaging studies.She underwent bronchoscopy, cervical mediastinoscopy, and right middle lobe wedge resection.The final pathologic diagnosis was a pulmonary carcinoid tumor, and the excised mediastinal lymph node was negative for malignancy.Reported complications include: a 10-month surveillance positron emission tomography scan showed new mildly avid mediastinal and right hilar lymph nodes.The following endobronchial ultrasound-guided transbronchial needle aspiration showed unremarkable lymphoid elements in the enlarged 4r ln, while the station 7 ln demonstrated ample dense hyaline-like foreign material.Subsequent review of the cell block/biopsy and communication with the thoracic surgeon revealed that surgicel® (or oxidized regenerated cellulose) was placed during surgery at the station 7 site.In conclusion, assessment of the findings and based on the similar histologic appearance reported in previous cases associated with surgicel® [ann thorac med.2017;12(1):55-6, cancer cytopathol.2019;127(12):765-70, and arch bronconeumol.2020;56(7):459-71], the station 7 acellular, amorphous, and hyaline-like exogenous material found in our case was interpreted as hemostatic agent compatible with surgicel® (or oxidized regenerated cellulose).This case highlights the importance of cytologic/histologic recognition of hemostatic agents, specifically oxidized cellulose mesh.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15185898
• MDR Text Key: 297491940
• Report Number: 2210968-2022-06369
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female