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-S

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

Patient Problem Peritonitis (2252)

Event Date 10/19/2013

Event Type  Injury  

Manufacturer Narrative

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 known clinical complication.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." 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

Cook became aware of a clinical literature article involving cook peg-24-pull-s devices in (b)(6) from december 2002- december 2012.The following are relevant excerpts: "peg tube placement has been proven to be a safe, effective procedure but sometimes complications can occur.Retrospective review was performed to identify the records of patients referred for peg or tube replacement at hanyang university hospital (seoul, korea) during the 10-year period between december 2002 to december 2012 (250 patients, 368 cases).A complication was considered as major if required medical intervention, tube removal, or hospitalization, including.Peritonitis [subject of report]." major complications were.Peritonitis in four [patients]." major surgery was required in one patient with peritonitis.Of 11 patients with internal bolster at upper body, major peg complications had occurred.Peritonitis in one [patient].The subject of this report is peritonitis in 4 patients as published in the article.This adverse event was previously reported in 1037905-2022-00232 and is now being captured separately in this report.

• 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 Contact: sabrina o'brien
• MDR Report Key: 14874497
• MDR Text Key: 295036820
• Report Number: 1037905-2022-00351
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

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
• Device Catalogue Number: PEG-24-PULL-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/30/2022
• 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