MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G22757
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear ziploc bag.A lot number was not with the returned device.In the photos provided the device is in a plastic bag and the bolster is detached, and the detached portion is not with device.Our laboratory evaluation of the product said to be involved confirmed the report.The feeding tube was returned with the bolster detached with only a small portion still attached to the tube.The detached portion was not returned.There was yellow brown substance inside the tubing.No other anomalies were detected with the device.The iqc records were pulled for the associated raw material lot for the tube which is tensile tested during inspection.The lot passed tensile testing indicating the product was conforming.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: the photos provided show the tube out and the bolster is detached/torn off.The returned device only had a small portion of bolster attached to the distal tip.The detached section was not returned.A definitive cause for the reported observation could not be determined.Prior to distribution, all pegs percutaneous endoscopic gastrostomy 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During a feeding tube placement, the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.It was reported [that] the gastrostomy tube ruptured, and a balloon-type g-tube was temporarily placed.Customer provided picture that shows the tube out of the patient, and the internal bolster is detached/torn off.The interna bolster is missing and the location is unknown.It is unknown if the patient required an additional procedure (further than a replacement tube) due to this detached/torn off bolster.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
During a feeding tube placement, the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.It was reported [that] the gastrostomy tube ruptured, and a balloon-type g-tube was temporarily placed.Customer provided picture that shows the tube out of the patient, and the internal bolster is detached/torn off.Additional information was received on 25 mar 2025 stating that the internal bolster of the complaint product was broken inside the patient's body.The doctor retrieved it during the patient's peg replacement, and since it was contaminated with some secretion, it was discarded.A section of the device did not remain inside the patient¿s body.The detached internal bolster was retrieved during the patient's peg replacement.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear ziploc bag.A lot number was not with the returned device.In the photos provided the device is in a plastic bag and the bolster is detached, and the detached portion is not with device.Our laboratory evaluation of the product said to be involved confirmed the report.The feeding tube was returned with the bolster detached with only a small portion still attached to the tube.The detached portion was not returned.There was yellow brown substance inside the tubing.No other anomalies were detected with the device.The iqc records were pulled for the associated raw material lot for the tube which is tensile tested during inspection.The lot passed tensile testing indicating the product was conforming.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: the photos provided show the tube out and the bolster is detached/torn off.The returned device only had a small portion of bolster attached to the distal tip.The detached section was not returned.A definitive cause for the reported observation could not be determined.Prior to distribution, all pegs percutaneous endoscopic gastrostomy 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (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: 21665412
• Report Number: 1037905-2025-00228
• Device Sequence Number: 15392633
• Product Code: KNT
• UDI-Device Identifier: 00827002226364
• UDI-Public: (01)00827002226364(17)250321(10)W4821986
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: G22757
• Device Catalogue Number: PEG-24-PULL-I-S
• Device Lot Number: W4821986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 65 KG