MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 3-0 D/A MH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8842H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Citation: https://doi.Org/10.18907/jjsre.45.6_403.
Event or Problem Description
Title: a case of suture and prejet of bronchus transection strayed into bronchus lumen 1 year and 3 months after radical lung cancer surgery.In (b)(6) 2019, a right lower confectionary s6 segmentectomy was performed for right lung cancer.At the time of surgery, b6a and b6b+c was bifurcated separately, and they were stapled together and dissected using a stapler (signia, camel cartridge, covidien); an air leak was observed from the b% transection, which was closed using a teflon prejet and the patient had an uncomplicated postoperative course.The postoperative pathological stage was ptlanomo, stage iai.One year and three months after the surgery without recurrence, the patient came to our hospital with a gradually worsening cough and dyspnea.On arrival, he was 158 cm tall, 42.1 kg in weight, blood ff130/84 mmhg, pulse 74/min, body temperature 36.2°c, and sp0298% (room air).Blood biochemistry findings: wbc 9100/ 1, neutro 72.1%, crp 4.81 mg/dl were all within normal limits, including tumor markers.Chest x-ray examination findings: low f permeability in the right lower lung field, loss of the right second arch, and findings suggestive of right middle lobe pneumonia were observed.Chest ct findings: a highly absorbent structure was seen closing most of the lumen of the right middle bronchial trunk.Clinical course: suspecting a bronchial foreign body, bronchoscopy was performed.The mucosa of the middle bronchial trunk was erythematous and edematous, and a white object was observed in the lumen.The object was removed bronchoscopically using biopsy forceps.The object was easily removed with no adhesion to the surrounding tissues at the time of removal.After removal of the foreign body, granulation formation was observed on the peripheral side of the bronchus, and the foreign bodies removed were prejet and prolene.It was not a control release needle.The patient was female, 67-year-old and discharged.One year and three months after the 1st surgery, the patient came to the outpatient because of worsening cough and dyspnea.After examination, a bronchial foreign body was suspected, and the patient underwent bronchoscopy removal of the foreign body.The foreign body was confirmed to be prejet and prolene.After treatment, the patient's symptoms improved and there was no recurrence of pneumonia.The doctor's decision is unknown.Wound healing of the resected bronchus begins with the growth of neovascular vessels.If a foreign body such as suture or a prejet is present, it is buried in the granulation tissue.However, this foreign body may cause chronic inflammation and the formation of intractable granulomas.Intraoperative air leaks were closed with horizontal mattress sutures using non-absorbable sutures (3-0 prolene) sandwiched between two teflon prejets.It is thought that granulation tissue formed during the healing process and the prejet and sutures strayed into the bronchial lumen.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested from the author, and the following was obtained: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? wound healing of the excised bronchus begins with the growth of new blood vessels.Fibroblasts proliferate, centering on new blood vessels, and granulation tissue is created.If a foreign body such as a suture or pledget is present here, it becomes embedded in granulation tissue.However, this foreign body may cause chronic inflammation and refractory granulomas may be formed.In this case, air leaks during the surgery were closed using horizontal mattress sutures using non-absorbable sutures (3-0 prolene) sandwiched between two teflon pledgets.During the healing process, granulation tissue forms and the pledgets and it is thought that the suture thread had strayed into the bronchial lumen.Which specific ethicon products have been used during the procedures (product code, lot number)? prolene.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.The same answer in the first question.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.No.Patient demographics? female, 67 years old.When she visited the hospital after the onset of symptoms, she was 158 cm tall and weighed 42.1 kg.

• Brand Name: PRLNE BLU 36IN 3-0 D/A MH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 19924930
• Report Number: 2210968-2024-08049
• Device Sequence Number: 16834444
• Product Code: GAW
• UDI-Device Identifier: 10705031021143
• UDI-Public: 10705031021143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 8842H
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female