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

Catalog Number	FLOW-20-PULL-SSK-S-T
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/11/2017
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 instruction for use indicates the following: "a thorough understanding of the technical principles, clinical applications and risk associated with placement and/or removal of a peg tube placement is necessary before using the device." 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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 a procedure, the physician used a flow 20 percutaneous endoscopic gastrostomy set - pull.As reported from medwatch mw5067337: "involves the portion of the peg tube (the introducer) [silicone feeding tub].The physician had difficulty threading a nylon through the introducer [silicone feeding tube], resulting in aborting the procedure.May have been secondary to user error, but unsure.Manager of endoscopy notified manufacturer." this event was not reported to the manufacturer from the user facility, as indicated in the medwatch.
Additional Manufacturer Narrative
An initial emdr was submitted on 2/23/2017 based on the following information: "during a procedure, the physician used a flow 20 percutaneous endoscopic gastrostomy set - pull.As reported from medwatch mw5067337: involves the portion of the peg tube (the introducer) [silicone feeding tub].The physician had difficulty threading a nylon through the introducer [silicone feeding tube], resulting in aborting the procedure.May have been secondary to user error, but unsure.Manager of endoscopy notified manufacturer.This event was not reported to the manufacturer from the user facility, as indicated in the medwatch.The medwatch report states contradictory information that hospitalization and a serious injury occurred due to this event, but that there was not an adverse event." additional information was provided from the user facility on 2/23/2017 and 3/9/2017 that there was no serious injury and a section of the device did not remain inside the patient body.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.Based on this information, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This additional information follow up report is being submitted to cancel the initial report submitted relating to this event.Please reference the additional manufacturer narrative notes for this justification.

• 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: 6354799
• Report Number: 1037905-2017-00074
• Device Sequence Number: 1002401
• Product Code: KNT
• UDI-Device Identifier: 00827002564039
• UDI-Public: (01)00827002564039(17)171207(10)W3804935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017
• Report Date (Section F): 01/17/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: FLOW-20-PULL-SSK-S-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/11/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/16/2017
• 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: Hospitalization
• Date Report Sent to FDA: 01/17/2017