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

Catalog Number PEG-24-PULL-I-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.The report was confirmed with the pictures provided.The photos show the device in the patient with discoloration around the stoma site.The third photo shows the skin around the feeding tube, into which the bumper seems to have sunk in.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided and statements describing the event.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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.However, the outer bolster of the device becoming buried, or "buried bumper syndrome", is a condition that can occur when too much traction is applied to the bolsters during placement.From the description of event and pictures provided, this is the most likely cause of this occurrence.The ifu warns, "excessive traction on the gastric feeding tube may cause premature removal, fatigue or failure of the device." the ifu additionally instructs, "bring the internal bumper in contact with the stomach wall, carefully avoiding excess tension," as well as "warning: the bolster should sit close to the skin but not tight against the skin.Excessive traction on the tube may cause premature removal, fatigue or failure of the device." the ifu states, "additional complications include, but are not limited to: pneumoperitoneum, peristomal wound infection and purulent drainage, stomal leakage, bowl obstruction, gastroesophageal reflux (gerd), and blockage or deterioration of the peg tube." prior to distribution, all peg 24 percutaneous endoscopic gastrostomy pull sets are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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.Additional comments: based on the information provided, a cook representative is being instructed to provide further education for the customer involved.

Event Description

A physician placed a cook peg 24 percutaneous endoscopic gastrostomy set - pull into the patient on (b)(6) 2021.It was initially reported by the patient's family to the physician that after 3 days from insertion, there is a swelling above the external bumper and external bumper was retracted to the skin.It seems like too tight to the skin [buried bumper].After 3 weeks from tube placement, the patient had swelling and leakage (food and pus found around the stoma).The patient returned back to the hospital where they confirmed a buried bumper.They removed the tube on (b)(6) 2021 and planned for a second procedure [placement].The second peg tube insertion was on (b)(6) 2022, with a new stoma.On (b)(6) 2022, some pus was found at the stoma and the patient had a follow up visit to the hospital on (b)(6) 2022 were they received treatment and care.The pus gradually decreased, now [at the time of complaint was] very less and patient's general prognosis is better.An unintended section of the device did not remain inside the patient¿s body.Due to the buried bumper, it was required to remove the existing peg and replace it with another peg tube.The pus was also treated by unknown treatment.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 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: 13423621
• MDR Text Key: 289340660
• Report Number: 1037905-2022-00040
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10827002227573
• UDI-Public: (01)10827002227573(17)221125(10)W4290635
• 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,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: PEG-24-PULL-I-S
• Device Lot Number: W4290635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female