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

Catalog Number	FLOW-20-PUSH-SSK-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
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 contains the following, "precautions: during placement and use, care must be taken to avoid cutting, crimping, or damaging components." the instructions for use states the following, "note: for wire guide removal, grasp the wire with a snare or non-spiked biopsy forceps at least 5 cm from the tip of the wire guide." "pull the wire guide to the tip of the endoscope, not into the endoscope channel." unraveling of the wire guide can occur if the snare is severely tightened onto the first 5 cm of the wire guide.If the wire guide experiences excessive pressure during use and/or general handling, damage to the wire guide can occur.Prior to distribution, all flow 20 percutaneous endoscopic gastrostomy set - push are subjected to a visual inspection to ensure device integrity.A review of the device history records confirmed that these lots met 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
In preparation for a procedure, the user selected two (2) cook flow 20 percutaneous endoscopic gastrostomy sets - push.The wire guide in the kit was not coming out of the race track port.When they tried to open the wire guide, the wire guide broke.This occurred with two devices from the same lot during this procedure.The devices did not make patient contact.The procedure was aborted due to these defective products.The patient will now require another procedure for the peg placement.

• Brand Name: FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6489971
• Report Number: 1037905-2017-00178
• Device Sequence Number: 11079699
• Product Code: KNT
• UDI-Device Identifier: 00827002315433
• UDI-Public: (01)00827002315433(17)171213(10)W3806172
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: FLOW-20-PUSH-SSK-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2017
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1