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

Model Number	G22637
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a percutaneous endoscopic gastrostomy (peg), the physician used two (2) cook flow 20 percutaneous endoscopic gastrostomy set - push devices.It was reported that there was a "deformity of the catheter during insertion at the moment of passage through the stomach.Another device was used with the same characteristics with the same result.The procedure cannot be carried out." it was also reported that there was no injury to the patient.This is interpreted to mean that there was difficulty passing the tube through the incision site during placement.A section of the device did not remain inside the patient¿s 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.
Additional Manufacturer Narrative
Initial reporter; occupation: non-healthcare professional.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided.
Additional Manufacturer Narrative
Section e.Initial reporter; occupation: non-healthcare professional.Investigation evaluation: the investigation is still on-going.A follow-up emdr will be provided.
Additional Manufacturer Narrative
Investigation evaluation: the two products said to be involved were returned in an open trays.One tray lid from the lot number provided in the report was returned.The label matches the product returned.For device #1, only the feeding tube and dilator were provided in the return.The distal end of the dilator appeared to be distorted starting at approximately 23 cm from the distal tip, and the dilator appeared to be twisted and damaged starting at approximately 5 cm from the distal tip.For device #2, only the feeding tube and dilator were provided in the return.The distal end of the dilator appeared to be distorted starting at approximately 25 cm from the distal tip, and the dilator appeared to be twisted and damaged starting at approximately 11 cm from the distal tip.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: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The damage at the distal tip observed can occur when the dilator is advanced over the wire guide.To assist the user, the ifu states, "using water-soluble lubricant and gauze, thoroughly lubricate the dilator and entire external length of the tube including the internal bumper.Advance the dilator tip over the wire guide and through the patient's mouth.Note: firm tension on both ends of the wire guide will ease passage through the oropharynx." prior to distribution, all percutaneuous endoscopic gastrostomy sets 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 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.

• 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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12898296
• Report Number: 1037905-2021-00653
• Device Sequence Number: 14653209
• Product Code: KNT
• UDI-Device Identifier: 00827002226371
• UDI-Public: (01)00827002226371(17)220416(10)W4461470
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2022

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: Health Professional
• Device Expiration Date: 04/16/2022
• Device Model Number: G22637
• Device Catalogue Number: FLOW-20-PUSH-S
• Device Lot Number: W4461470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 01/07/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown