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

Catalog Number FLOW-20-PULL-I-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2023

Event Type  Injury  

Event Description

During a feeding tube placement, the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - pull.It was reported that the patient returned to the hospital in the emergency room for accidental peg removal.The patient underwent fluoroscopy to have another feeding tube placed.During fluoroscopy, the internal dome bolster of the peg tube that fell out was discovered in the stomach.Then the patient underwent an endoscopy to remove the foreign body (dome) from the stomach.The internal bolster section of the device detached inside the patient's body.The patient underwent an endoscopy to remove the foreign body (internal bolster) from the stomach.No further adverse effects were reported.

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.The subassembly lot number associated with the feeding tube/bolster was reviewed and a discrepancy or anomaly was not observed with the product that was released for manufacturing.The iqc records were pulled for the associated raw material lot which is tensile tested during inspection.The lot passed tensile testing indicating the product was conforming.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.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.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 - PULL
• Type of Device: 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: 18605730
• MDR Text Key: 334092323
• Report Number: 1037905-2024-00052
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10827002227610
• UDI-Public: (01)10827002227610(17)260210(10)W4700324
• Combination Product (y/n): N
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: FLOW-20-PULL-I-S
• Device Lot Number: W4700324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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
• Treatment: UNKNOWN ENDOSCOPE MAKE & MODEL
• Patient Outcome(s): Other