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

Catalog Number	FLOW-20-PUSH-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The coil spring of the wire guide unraveled at 156.9 cm from the proximal end all the way to the distal tip.There was a portion on the distal tip that has a sharp portion on the tip.There were multiple bends and kinks at 34.5 cm, 81.5 cm, 157.9 cm, 164.5 cm and 254.3 cm.There were portions of the core wire, safety wire, and coil spring that appear to be missing and not provided with the return.Approximately 10 cm of the distal end of wire guide appeared to be missing.Measurement of the diameter of the core wire showed that it was broken along the taper when the device was 0.009" in diameter.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 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 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 sets - 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.
Event or Problem Description
During a percutaneous endoscopic gastrostomy (peg), the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - push.In the placement of the gastrostomy tube, at the moment of the traction to externalize [through] the abdominal wall, the guide [wire] frayed.There was no reportable information at this time.Additional information was received on 25-may-2018: a portion of the wire guide detached inside the stomach and was removed with forceps, used for foreign body retrieval.A section of the device did not remain inside the patient's body.The detached portion of the wire guide was removed with forceps due to this occurrence.According to the initial report, the patient did not experience any adverse effects due to this occurrence.

• 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: 7615135
• Report Number: 1037905-2018-00265
• Device Sequence Number: 2067015
• Product Code: KNT
• UDI-Device Identifier: 00827002226371
• UDI-Public: (01)00827002226371(17)181204(10)W4002948
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2018
• Device Catalogue Number: FLOW-20-PUSH-S
• Device Lot Number: W4002948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GIF-Q150 ENDOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 80