MAUDE Adverse Event Report: COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G56403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional 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 instructions for use (ifu) precautions: "the benefit of a peg tube to the patient must be weighed against the risks associated with any indwelling gastronomy feeding tube." prior to distribution, all flow 20 percutaneous endoscopic gastrostomy set - pull 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.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
The following information was provided to cook by the user: this was a new peg placement.There were no issues during the placement [of the device].The placement was verified endoscopically, the bumper was appropriately noted in relation to the skin.The peg site became infected prior to being utilized for feedings, as it was placed for use post chemo and radiation for a neck/throat cancer.The patient returned to the gastro-intestinal (gi) lab within seven (7) days of the initial peg placement as a result of being seen by the oncologist.Additional information was received on 01-may-2019: the device was placed (b)(6) 2019 [with] no issues.[the patient] returned (b)(6) 2019 [with an] infection [that was] treated with oral antibiotics with success.Several attempts were made in an attempt to collect additional information regarding patient impact and product usage.It is unknown if a section of the device remained inside the patient's body.The patient required antibiotics due to this occurrence.Because the complainant stated that the infection was treated with success, we can conclude that this information does not reasonably suggest the patient was adversely impacted.

• Brand Name: FLOW 20 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: 8625127
• Report Number: 1037905-2019-00259
• Device Sequence Number: 13938511
• Product Code: KNT
• UDI-Device Identifier: 00827002564039
• UDI-Public: (01)00827002564039(17)191031(10)W4138734
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: G56403
• Device Catalogue Number: FLOW-20-PULL-SSK-S-T
• Device Lot Number: W4138734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/20/2019
• 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