MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Meningitis (2389); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon product (nurolon suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (nurolon suture ) involved? citation: world neurosurg.2014; 82, 6s: s54-s58.Doi: http://dx.Doi.Org/10.1016/j.Wneu.2014.07.027 postoperative sinonasal care continues in the outpatient setting with the otolaryngologist 1 week postoperatively.Endoscopic débridement of the sinonasal cavity is performed, and the cranial base is carefully inspected for a cerebrospinal fluid leak.Loose secretions and breakdown products from tissue sealants and hemostatic agents can be suctioned and removed.Crusting along the skull base reconstruction site is not instrumented until the scabs are no longer adherent to the skull base.Endoscopic débridements result in less crusting and synechia formation compared with the use of saline alone (4).Patients begin saline irrigation after the 1-week postoperative visit and return 3 weeks postoperatively for another débridement.(b)(4).

Event Description

It was reported via journal article "title: comprehensive management of the paranasal sinuses in patients undergoing endoscopic endonasal skull base surgery" authors: gurston g.Nyquist, marc r.Rosen, mark e.Friedel, d.David beahm, christopher j.Farrell, james j.Evans citation: world neurosurg.2014; 82, 6s: s54-s58.Doi: http://dx.Doi.Org/10.1016/j.Wneu.2014.07.027 the endonasal route often provides the most direct and safe approach to skull base pathology.In the article, the authors reviewed the literature with regard to management of the paranasal sinuses in the setting of skull base surgery.The authors described the institutional experience and review of literature of concurrent management of sinusitis in patients undergoing endoscopic skull base surgery.Patients with chronic rhinosinusitis (crs) with or without polyps can be surgically addressed at the time of skull base surgery.A review of 250 consecutive cases since march 2009 in our database revealed 20 patients who underwent the procedure and were included in the study.The authors described the use of a ¿button graft¿ technique for repair of skull base defects.The 2 grafts are sutured together using nurolon 4-0 sutures (ethicon) and placed with the inlay portion intradurally and the onlay portion extradurally.Reported post-operative complications included acute rhinosinusitis (2%) and meningitis or intracranial abscess (0.7%).The careful management of the paranasal sinuses is paramount to maintain healthy sinonasal function in patients undergoing endoscopic endonasal skull base surgery.Careful management of the paranasal sinuses throughout the peri-operative course is paramount to optimizing sinonasal function and safety.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8033355
• MDR Text Key: 125961888
• Report Number: 2210968-2018-76904
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention