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-I-S

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

Patient Problems Abdominal Distention (2601); Increased Intra-Peritoneal Volume (IIPV) (4498)

Event Date 11/23/2022

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.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.The complications reported 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 or inability to place peg tube, tube dislodgement or migration, hemorrhage, and tumor metastasis.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 percutaneous endoscopic gastrostomy sets are subjected to a visual and functional inspection 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: 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

During a gastronomy feeding tube placement, the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.It was reported [that seven days after tube placement] patient has fever, slight redness and swelling of the upper abdominal wall, [and] subcutaneous touch hairtwist sensation in the upper abdomen.Abdominal ct showed that the gastrostomy tube protruded subcutaneously and subcutaneous accumulation of fluid and gas in the upper abdominal wall.A section of the device did not remain inside the patient's body.The patient experienced fever, slight redness, and swelling of the upper abdominal wall and required emergency room visit due to this occurrence.Emergency treatment included subcutaneous exploration of the abdominal wall and debridement to place gastronomy tube.

• 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: 15996963
• MDR Text Key: 305623041
• Report Number: 1037905-2022-00685
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10827002227573
• UDI-Public: (01)10827002227573(17)241228(10)W4550213
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PEG-24-PULL-I-S
• Device Lot Number: W4550213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• 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
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female