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 Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Peritonitis (2252); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 10/19/2013

Event Type  Injury  

Event Description

Cook became aware of a clinical literature article involving cook peg-24-pull-s devices in korea 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).Minor complications were peristomal infection (for cases where the existing peg was not removed or exchanged) and minor bleeding or injury (oral cavity, gi tract, skin wound) [subject of this report].[minor] complications were observed in 27 [patients].Table 1 outlines the following data: minor complications- 27, which include: esophageal injury with minor bleeding- 22 minor peristomal infection- 4 huge bezoar- 1" this article is under investigation.Separate reports may be sent to capture different severities upon completion of the investigation.

Manufacturer Narrative

This article is under investigation.A follow up report will be sent.Doi: 10.1007/s10620-013-2891-7.

Manufacturer Narrative

This article remains under investigation.A follow up report will be sent.Doi: 10.1007/s10620-013-2891-7.

Manufacturer Narrative

Doi: 10.1007/s10620-013-2891-7.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.Bleeding, peritonitis, necrotizing fasciitis, migration, and infection 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 became aware of a clinical literature article involving cook peg-24-pull-s devices in korea 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).Minor complications were peristomal infection (for cases where the existing peg was not removed or exchanged) and minor bleeding or injury (oral cavity, gi tract, skin wound) [subject of this report].[minor] complications were observed in 27 [patients].Table 1 outlines the following data: minor complications- 27, which include: esophageal injury with minor bleeding- 22, minor peristomal infection- 4, huge bezoar- 1." note: this article is under investigation.Separate reports may be sent to capture different severities upon completion of the investigation." the subject of this report is now the following: intramural hematoma of esophagus- 1 patient peritonitis- 3 patients.Necrotizing fasciitis- 3 patients.Buried bumper syndrome- 7 patients.Peristomal infection requiring tube removal- 3 patients.Minor peristomal infection- 4 patients.The implanted peg remained in the patient's body as intended.The adverse effects and additional procedures published in the article are outlined in the description of event.

• 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: 14458872
• MDR Text Key: 293940498
• Report Number: 1037905-2022-00233
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 04/22/2022
• 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