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

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 01/11/2017

Event Type  Injury  

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 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.

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 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
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6354799
• MDR Text Key: 68210399
• Report Number: 1037905-2017-00074
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002564039
• UDI-Public: (01)00827002564039(17)171207(10)W3804935
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2017,03/16/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: FLOW-20-PULL-SSK-S-T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Distributor Facility Aware Date: 01/11/2017
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization