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

Model Number	G22757
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.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 stock photo was provided to clarify that the internal bolster had detached.The photo does not contain an image of the complaint device.A review of tensile test data for the tube and bolster was performed and it was verified that the sample device units met the acceptable criteria.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 instruction for use indicate the following: "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 instruction for use indicate the following: "cut the tube at the x mark." extra length may cause the feeding tube to move around more and make it easier for the feeding tube to be pulled on."excessive traction on the gastric feeding tube may cause premature removal, fatigue, or failure of the device." prior to distribution, all peg 24 percutaneous endoscopic gastrostomy sets - pull are subjected to a visual 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 or Problem Description
During an endoscopic procedure, the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.The device was placed in the patient according to the instructions.The cap [bolster] detached one (1) week after placement of the device.The device with the cap detached was replaced by another of the same product.Additional information was received on 04-jul-2019 indicating that the detached portion was the bolster of the device.Additional information was received on 15-jul-2019: the detached portion was allowed to pass naturally.The bolster remained inside the patient¿s body to pass naturally.The patient did not require any additional procedures due to this occurrence.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
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8795218
• Report Number: 1037905-2019-00394
• Device Sequence Number: 2044024
• Product Code: KNT
• UDI-Device Identifier: 00827002227576
• UDI-Public: (01)00827002227576(17)211105(10)W4139926
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K912047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 11/05/2021
• Device Model Number: G22757
• Device Catalogue Number: PEG-24-PULL-I-S
• Device Lot Number: W4139926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75