MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A BP-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D9424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930)
Date of Event	01/01/2023
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.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.Additional information was requested, and the following was obtained: it was stated that when the chest was opened, ¿two of the three pds stitches had been cut¿.Please confirm: did 1 suture break post-op? if more than 1 suture broke post-op, please explain.2 sutures were broke off post-op.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.The patient's background is that he is a large, muscular man with a large past medical history and was a carrier of mrsa.Date and name of index surgical procedure? 2023.The date is unk.The diagnosis and indication for the index surgical procedure? lung cancer.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.On what tissue was the suture used? the suture used intercostal space.The approach was posterolateral thoracotomy method.What tissue dehisced? intercostal space.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk.How was the suture placed (interrupted or continuous)? interrupted (z suturing).How was the suture tied (square knot or multiple knots one end)? interrupted (z suturing).Onset date/time of dehiscence? (# post op days) 15 days.How was the dehiscence managed? reoperation and did not suture intercostal space.The detail is unk.Please describe any surgical intervention required for the wound dehiscence including date and findings.Reoperation and did not suture intercostal space.The detail is unk.Please describe the appearance of the suture during the second procedure.Reoperation and did not suture intercostal space.The detail is unk.Were there any patient stress factors that precipitated the event of suture breakage post op? unk.When did the bleeding occur? the venous blood vessels were probably sutured during the first surgery, and hemothorax probably occurred when the sutures broke.What was the source and triggering event of bleeding? the venous blood vessels were probably sutured during the first surgery, and hemothorax probably occurred when the sutures broke.What was the volume of blood loss? unk.How was the bleeding treated? reoperation and did not suture intercostal space.The detail is unk.How was the hemothorax managed? reoperation and did not suture intercostal space.The detail is unk.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? no.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Wound infection.Please provide the onset date/time of infection from the initial surgical procedure.Unk.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? the patient was a carrier of mrsa.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unk.Were cultures performed? if so, please provide the results.Unk.How much and what type of drainage is present in this wound? unk.Please describe any medical intervention performed for the infection including medication name and results.Unk.Were any pre-op cleansing procedures changed recently? if yes, please describe.No.What symptoms did the patient experience following the index surgical procedure? onset date? unk.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? unk.What is the patient's current status? extension of hospitalization.Lot number? unk.If applicable, will product be returned? if so, please provide the return date and tracking information.The products have been disposed of at the hospital.Related medwatch reports: 2210968-2023-05607.
Event or Problem Description
It was reported that a patient underwent a respiratory procedure on an unknown date in 2023 and suture was used at the intercostal space.It was stated that this case was a surgery in which a malignant lobectomy was planned but could not be resected and the chest was closed.The chest was opened posterolaterally and approached from the back.Post-op, 15 days after the procedure, hemothorax occurred during a physical examination and was treated urgently.A wound dehiscence also occurred.When the chest was opened, two of the three suture stitches had been cut.They were stitched with z sutures.It was opined that when suturing the intercostal space, the venous vessels were also sutured together, and the hemothorax may have occurred at the same time the threads were broken.Hemothorax occurred and reopening chest procedure.The patient's hospital stay was prolonged because of the wound infection.The patient was hospitalized with concomitant ssi.Additional information was requested.

• Brand Name: PDSII VIO 36IN 0 S/A BP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• 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: 17890129
• Report Number: 2210968-2023-07509
• Device Sequence Number: 7551614
• Product Code: NEW
• UDI-Device Identifier: 10705031033054
• UDI-Public: 10705031033054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D9424
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• 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: Required Intervention
• Patient Sex: Unknown