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

Catalog Number	FLOW-20-PULL-I-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.A product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.The report was confirmed with the pictures provided.The photo provided of x-ray shows the bolster in the patient's digestive tract.The feeding tube is discolored and has the inner ring of the bolster connected to the tip.The bolster's inner ring is damaged with a large section of silicone missing.It cannot be determined if any sections of the bolster are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed.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 instruction for use indicate the following: "warning: the bolster should sit close to the skin but not tight against the skin.Excessive traction on the tube may cause premature removal, fatigue, or failure of the device." the instruction for use indicate the following: "cut the tube at the x mark." extra length may cause the feeding tube to move around more and make it easier for the feeding tube to be pulled on."excessive traction on the gastric feeding tube may cause premature removal, fatigue, or failure of the device." prior to distribution, all flow 20 percutaneous endoscopic gastrostomy sets - push 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
The following information was provided to cook by the user regarding a cook flow 20 percutaneous endoscopic gastrostomy set - pull.A peg flow-20 was placed (b)(6) 2018.The patient came back (b)(6) 2018 because the bumper came off.It was in the small intestine [noted] after the x-ray.After two (2) days the patient passed it out through the rectum.The inner bolster remained inside the patient's body to pass naturally.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient had to be admitted due to this occurrence.

• Brand Name: FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7813724
• Report Number: 1037905-2018-00372
• Device Sequence Number: 11097269
• Product Code: KNT
• UDI-Device Identifier: 00827002227613
• UDI-Public: (01)00827002227613(17)210417(10)W4057730
• Combination Product (Y/N): N
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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: 04/17/2021
• Device Catalogue Number: FLOW-20-PULL-I-S
• Device Lot Number: W4057730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization