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 Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

This event is under investigation.A follow up emdr will be provided.Wisam sbeit, anas kadah, amir shahin, samer shbat, moeen sbeit & tawfik khoury (2021) scheduled percutaneous endoscopic gastrostomy tube replacement did not reduce peg-related complications, scandinavian journal of gastroenterology, 56:11, 1386-1390, doi: 10.1080/00365521.2021.1965209.

Event Description

Cook endoscopy was notified of this event involving cook peg tubes via a clinical literature article.This article was published in 2021.Please see below for relevant excerpts of this article.We conducted a cross-sectional, retrospective study, using the databases of (b)(6) medical center.We use bumper-type gastrostomy tubes of 24 french (fr) (by cook) for the first insertion and the balloon-type replacement tubes of 18 fr and 24 fr of the same company for a replacement.Our replacement policy after peg insertion is to replace the tube on demand, in cases of inadvertent removal, tube malfunction or destruction, and leak or obstruction that mandate removal of the tube and replacing it, but it doesn¿t include a scheduled replacement in accordance with the manufacturer recommendations as we have noticed that tubes may function for longer period of time.Peristomal leak was defined by leakage of gastric or feed contents from around the peg insertion site [subject of this report].34 patients experienced a peristomal leak.It was not reported if an unintended section of the device remained inside the patient¿s body.It was not published that what interventional procedures were required due to this occurrence.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.See h10 additional manufacturer notes for futher justification.

Manufacturer Narrative

Upon completion of the investigation of the article after the initial emdr was sent, we have determined that this event (peristomal leakage) does not meet fda reporting criteria.The information states that there was a peristomal leak.Historically, a peristomal leak has not caused or contributed to a serious injury or death.A peristomal leak occurs when gastric fluid leaks from the stoma.Intervention may be required; however it would not rise to the level of intervention to preclude serious injury or death.Therefore, this is no longer considered reportable.

• 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): 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: 14459208
• MDR Text Key: 292209949
• Report Number: 1037905-2022-00237
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 06/16/2022

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-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