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

Model Number	G22636
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional 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.The report was confirmed with the pictures provided.Three (3) pictures were provided by the user.The first picture is an x-ray image of the device bumper inside the patient's intestine.The second picture is a photo of the report concerning the peg placement procedure and includes photos of the internal bumper.The third picture shows the explanted device which is missing the internal bumper.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based on the pictures provided and statements describing the event.The device history record for the lot number and subassembly lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.The iqc record for the lot of cpn involved was reviewed and indicated that there was no issue with the product in terms of tensile strength.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." 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
After a percutaneous endoscopic gastrostomy (peg) ,where the physician used a peg 24 percutaneous endoscopic gastrostomy set ¿ pull, there was dislodgement of the tulip tip [bolster].Per additional information received on 26 oct 2020: peg-24-pull placed on (b)(6) 2020.On (b)(6) 2020, patient came to the hospital complaining of dislodgement of tube; then the doctor saw the missing tulip tip (bumpers) on the tube.Then immediately took x-ray and found the tube in intestines and took needed steps to remove the tube (bumper).The bolster of the device detached inside the patient¿s body.The patient underwent colonoscopy to remove the bolster.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: 10836613
• Report Number: 1037905-2020-00483
• Device Sequence Number: 14334191
• Product Code: KNT
• UDI-Device Identifier: 00827002226364
• UDI-Public: (01)00827002226364(17)210327(10)W4335229
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: G22636
• Device Catalogue Number: PEG-24-PULL-S
• Device Lot Number: W4335229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR