MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

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 products 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 products used in this procedure? citation: journal of pediatric surgery 52 (2017) 1117¿1120; doi: http://dx.Doi.Org/10.1016/j.Jpedsurg.2016.12.014.(b)(4).

Event Description

Journal article title: ¿is fundoplication required after the foker procedure for long gap esophageal atresia? this retrospective chart review aimed to present the authors¿ experience pharmacological management and endoscopic surveillance rather than early routine fundoplication in infants treated with the foker procedure.Since may2007, foker procedure has been performed in 9 consecutive patients (n=4 male and n=5 female) with long gap esophageal atresia for which the procedure was performed via open thoracotomy (n=2) and thoracoscopically (n=7).In the procedure, one to three 4/0 prolene® sutures are placed in a ¿figure 8¿ configuration to reduce the chance of them tearing out.The sutures are tied to and then rolled over a piece of silastic tubing.Tightening is done either daily or twice daily and then secured to the chest wall using adhesive tapes.Patient #5 (operated at 9-day-old) developed a small extrapleural abscess related to the traction sutures that required intravenous antibiotics and was washed out at the time of the definitive anastomosis.The study demonstrates the success of the foker procedure in managing lgea, as well as the applicability of minimally invasive techniques in this setting¿.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.It was reported that this device is not malfunction reportable.Therefore, this medwatch report 2210968-2018-73862 is not reportable.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7640364
• MDR Text Key: 112429519
• Report Number: 2210968-2018-73862
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/14/2018
• 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