MAUDE Adverse Event Report: COOK ENDOSCOPY PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number PEG-24-PULL-S

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

Patient Problem Peritonitis (2252)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: age at time of event: the patients¿ mean age was 77.8±15.9 with female predominance (53.3%).Gender: there was a female predominance (53.3%) in the study; male 70 (46.7%).Citation: miranda le, penha mrcd, miranda acg, lima dl, costa mwf, amorim ao.Risk factors associated with early mortality after percutaneous endoscopic gastrostomy in patients at a tertiary care center in brazil: a retrospective single-center survival study.Arq gastroenterol.2019 oct-dec;56(4):412-418.Doi: 10.1590/s0004-2803.201900000-83 the investigation is currently in progress.A follow-up emdr will be sent following the completion of the investigation.

Event Description

Cook endoscopy was notified of this event via a clinical literature article in regard to a cook peg 24 percutaneous endoscopic gastrostomy set - pull.This article was published in 2019.Please see below for relevant excerpts of this article.¿patients with swallow dysfunction treated with peg [percutaneous endoscopic gastrostomy] between january 2012 and december 2016.Upon endoscopic observation, a place in the anterior wall of the distal fornix was chosen and a puncture was made at this point through the abdominal wall using a needle 16 gauge until it reached the stomach lumen.Through this needle was delivered a guide wire, which was taken by a loop and externalized via the patient¿s mouth.This guide was attached to a peg tube.The surgeon drew the guide wire through the abdominal wall, taking the tube from the mouth to the stomach and externalizing it through the abdominal wall.A silicone dome at the end of the probe prevents it from being drawn out of the stomach.The external bolster of the peg kit was placed, keeping the probe attached to the abdominal wall and the stomach in juxtaposition to the inner abdominal wall.This creates a fistula between the stomach and the external environment through which the patient can be fed.The round external bolster was fixed to the skin with 3.0 nylon stitches and the same wire was attached to the gastrostomy tube, prevent¬ing it from moving into the abdomen.The stitches were removed by the surgical team itself 48¿72 hours after the procedure and the tube was loosened by 0.5 cm to avoid the buried bumper syndrome.The patients were kept under observation of the responsible team until recovery from sedation and then sent to the hospital sector of origin.Six hours after the procedure, as long as no postoperative complications were observed, feeding was allowed partially by the gastrostomy tube, and after 24 hours, they were fed according to the nutritional demands of each patient.Either an endovivetm enteral access initial placement system (24fr peg-kit, boston scientific, marlborough mass, usa) or a peg 24® pull method kit (cook endoscopy, indiana, usa) was used at the endoscopist¿s judgment.The following complications were defined.Peritonitis¿ inflammation (caused by extravasation of gastric contents or food) of the membrane lining the abdominal wall, which then covers the abdominal organs;.Overall, 32 patients had peg-related complications.Early complications during the first week following peg were as follows.,peritonitis in 3 (2.0%) [subject of this report].We did not change peg tube due to any tube malfunction.¿ a section of the device did not remain inside the patient¿s body that was reported within the clinical literature article other than the intended peg tube.While an intervention was not specified within the article, it is assumed that the patient required antibiotics and/or surgical intervention to treat the peritonitis.

Manufacturer Narrative

Patient information: age at time of event: the patients¿ mean age was 77.8±15.9 with female predominance (53.3%).Gender: there was a female predominance (53.3%) in the study; male 70 (46.7%).Citation: miranda le, penha mrcd, miranda acg, lima dl, costa mwf, amorim ao.Risk factors associated with early mortality after percutaneous endoscopic gastrostomy in patients at a tertiary care center in brazil: a retrospective single-center survival study.Arq gastroenterol.2019 oct-dec;56(4):412-418.Doi: 10.1590/s0004-2803.201900000-83.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Peritonitis is a well know clinical complication.There is no evidence to suggest the report is due to a device failure.The instructions for use states the following potential complications: ¿potential complications associated with placement and use of a peg tube include, but are not limited to: bronchopulmonary aspiration and pneumonia, respiratory distress or airway obstruction, peritonitis or septic shock, colocutaneous, gastrocolocutaneous or small bowl fistula, gastric dilation, sigmoid intra-abdominal herniation and volvulus, persistent fistula following peg removal, esophageal injury, necrotizing fasciitis, candida cellulitis, improper placement of inability to place peg tube, tube dislodgement or migration, hemorrhage, and tumor metastasis.".Prior to distribution, all peg 24 percutaneous endoscopic gastrostomy set - pull are subjected to a visual and functional inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11332526
• MDR Text Key: 232000782
• Report Number: 1037905-2021-00062
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PEG-24-PULL-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention