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

Catalog Number PEG-24-PULL

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

Patient Problems Pneumothorax (2012); Peritonitis (2252); Post Operative Wound Infection (2446); Aspiration Pneumonitis (4455); Respiratory Arrest (4461); Pancreatitis (4481)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Cook endoscopy was notified of this event via a clinical literature article and involves the use of a cook peg 24 percutaneous endoscopic gastrostomy set - pull (peg-24-pull-s).This article was published in 2022.Please see below for relevant excerpts of this article."this retrospective study included patients who underwent peg at the (b)(6) hospital in (b)(6) between january 2013 and december 2018.A gastroenterologist performed all peg procedures using the pull technique, and all patients were followed up for >3 weeks postoperatively.Complications and mortality.Table 6 lists the complications that occurred within 2 days after peg tube insertion.Ten out of the 151 patients who were enrolled experienced the following complications after peg tube insertion: postoperative pneumoperitoneum (four patients), aspiration pneumonia (four patients), postoperative pancreatitis with peritonitis (one patient), surgical site infection (one patient), and respiratory arrest (one patient).One patient experienced both aspiration pneumonia and pneumoperitoneum.All patients recovered without surgical intervention.Overall, 10 patients experienced short-term complications related to peg tube insertion in this study.On the other hand, none of these complications were fatal and the patients recovered without surgical intervention." it is assumed that intervention was performed for the published complications, but specifics were not published in the article.Note: these events are still under review and investigation.Separate reports to further capture the different severities of complications may be submitted based on the outcome of the investigation.

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.Note: these events are still under review and investigation.Additional, separate reports may be submitted based on the outcome of the investigation.Literature review - nutritional impact of percutaneous endoscopic gastrostomy: a retrospective single-center study korean j gastroenterol vol.79 no.1, 12-21 https://doi.Org/10.4166/kjg.2021.086 pissn 1598-9992 eissn 2233-6869.

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Manufacturer Narrative

Literature review - nutritional impact of percutaneous endoscopic gastrostomy: a retrospective single-center study.Korean j gastroenterol vol.79 no.1, 12-21 https://doi.Org/10.4166/kjg.2021.086.Pissn 1598-9992 eissn 2233-6869.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.Infection, pneumonia, and pneumoperitoneum are known clinical complications.There is no evidence to suggest the report is due to a device failure.The ifu 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." the ifu also states, "additional complications include, but are not limited to: pneumoperitoneum, peristomal wound infection and purulent drainage, stomal leakage, bowel obstruction, gastroesophageal reflux (gerd), and blockage or deterioration of the peg tube." 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: 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.

Event Description

The following was originally reported: "cook endoscopy was notified of this event via a clinical literature article and involves the use of a cook peg 24 percutaneous endoscopic gastrostomy set - pull (peg-24-pull-s).This article was published in 2022.Please see below for relevant excerpts of this article."this retrospective study included patients who underwent peg at (b)(6) hospital in korea between (b)(6) 2013 and (b)(6) 2018.A gastroenterologist performed all peg procedures using the pull technique, and all patients were followed up for >3 weeks postoperatively.Complications and mortality.Table 6 lists the complications that occurred within 2 days after peg tube insertion.Ten out of the 151 patients who were enrolled experienced the following complications after peg tube insertion: postoperative pneumoperitoneum (four patients), aspiration pneumonia (four patients), postoperative pancreatitis with peritonitis (one patient), surgical site infection (one patient), and respiratory arrest (one patient).One patient experienced both aspiration pneumonia and pneumoperitoneum.All patients recovered without surgical intervention.Overall, 10 patients experienced short-term complications related to peg tube insertion in this study.On the other hand, none of these complications were fatal and the patients recovered without surgical intervention." it is assumed that intervention was performed for the published complications, but specifics were not published in the article.Note: these events are still under review and investigation.Separate reports to further capture the different severities of complications may be submitted based on the outcome of the investigation." the subject of this report is now the following: ".Postoperative pneumoperitoneum (four patients), aspiration pneumonia (four patients), postoperative pancreatitis with peritonitis (one patient), surgical site infection (one patient).One patient experienced both aspiration pneumonia and pneumoperitoneum.All patients recovered without surgical intervention." the respiratory arrest previously captured under this report will now be captured under a separate emdr.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 14453326
• MDR Text Key: 292384630
• Report Number: 1037905-2022-00226
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PEG-24-PULL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• 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