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

Model Number	G22637
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a percutaneous endoscopic gastrostomy (peg), the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - push device.It was reported that the problem occurred during placement about half way through the procedure.When they [physician] snared the wire, the wire got a kink in it.When they went to pull it, the kink caused the guide wire to fray.They had to struggle to get the peg placed with the guide wire.The procedure was successfully completed with the device in question.There was no reportable information at this time.The device retuned and during the evaluation it was noted that the distal end of the wire guide was fully severed at approximately 1.5 cm - 1.6 cm and 36.8 cm from the distal end.[subject of report] 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
Investigation evaluation: the product said to be involved was returned in an open tray from the lot number provided in the report.The label matches the product returned.The device did not return with all accessories included in the kit.Our evaluation of the product said to be involved confirmed the report.The dilator was kinked/damaged at the distal end.The distal end of the wire guide was fully severed at approximately 1.6 cm and 36.8 cm from the distal end with an uncoiled portion of wire guide approximately 1.9 cm long at the proximal end.The device is uncoiled and kinked through its length.The core wire has frayed 203.2 cm and 204.3 from the distal end of the long portion of the returned wire guide.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: our laboratory investigation confirmed the wire guide was kinked and uncoiled throughout the length as well as broken in two places.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use cautions the user: "during placement and use, care must be taken to avoid cutting, crimping, or damaging components." the instructions for use states the following: "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." prior to distribution, all flow 20 percutaneous endoscopic gastrostomy set - push devices are subjected to a visual inspection 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.

• Brand Name: FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 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: 15133902
• Report Number: 1037905-2022-00427
• Device Sequence Number: 6482401
• Product Code: KNT
• UDI-Device Identifier: 00827002226371
• UDI-Public: (01)00827002226371(17)221216(10)W4547537
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 12/16/2022
• Device Model Number: G22637
• Device Catalogue Number: FLOW-20-PUSH-S
• Device Lot Number: W4547537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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 Age: 66 YR
• Patient Sex: Female