MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number FLOW-20-PULL-S

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

Patient Problems Hemorrhage/Bleeding (1888); Pneumonia (2011); Post Operative Wound Infection (2446)

Event Date 01/01/2007

Event Type  Injury  

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.Separate reports to further capture the different severities of complications may be submitted based on the outcome of the investigation.Literature review: outcomes of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy tube insertion at a (b)(6) hospital.(b)(6).2212-8263/36.00 2012 (b)(6) society for clinical nutrition and metabolism.Published by elsevier ltd.All rights reserved.Doi:10.1016/j.Clnme.2012.05.001.

Event Description

Cook endoscopy was notified of this event involving flow 20 percutaneous endoscopic gastrostomy set - pull via a clinical literature article.This article was published in 2012.Please see below for relevant excerpts of this article.A retrospective analysis was conducted on all patients who had an initial peg.Inserted at the (b)(6) hospital between january 2007 and april 2009.The most common types of pegs inserted were the flow 20 pull gastrostomy system (cook medical, in, usa).Between january 2007 and april 2009, 177 gastrostomy tubes (peg: 80) were inserted the main indications for gastrostomy insertion were stroke (23%), head and neck cancer (27%) and trauma (25%).Prophylactic antibiotics were given.Table 3 outlines the following post-procedural complications for peg: stoma site infection 11.Pneumonia 4.Bleeding 1.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.

Manufacturer Narrative

Literature review - outcomes of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy tube insertion at a tertiary hospital.Australia.2212-8263.2012 european society for clinical nutrition and metabolism.Published by elsevier ltd.All rights reserved.Doi:10.1016/j.Clnme.2012.05.001 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 bleeding 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 flow 20 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.

• Brand Name: FLOW 20 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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14468848
• MDR Text Key: 292358595
• Report Number: 1037905-2022-00235
• 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,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FLOW-20-PULL-S
• 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