MAUDE Adverse Event Report: COOK ENDOSCOPY PASSPORT LOW PROFILE GASTROSTOMY DEVICE; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number G24612

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the picture provided, the device bolster has been punctured and a portion of the distal tip is missing.Red discoloration can be seen inside the bolster.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photo provided and statements describing the event.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 instructions for use provides the following information: "generously lubricate stoma site and conical tip of selected passport using water soluble lubricant only.Caution: use of non-water soluble lubricant may cause damage to passport.Lubricate obturator and insert it though valve opening on top of device.Advance obturator into conical tip.Continue advancing obturator to elongate tip.Flatten elongated conical tip against obturator to aid insertion.Using a slight twisting motion in direction of stoma tract, advance elongated conical tip fully into stomach." the obturator being off centered when the device was elongated for placement could have contributed to this occurrence.If the passport device was subjected to excessive pressure during elongation for placement, this could have contributed to the reported occurrence.Prior to distribution, all passport-low profile gastrostomy tubes are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: 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 Description

In preparation for a procedure, the user selected a cook passport low profile gastrostomy device.The patient underwent an attempt to change a gastrostomy device, however, it was not possible because during the traction of the button tip for introduction into the stomach, it [the button] was injured [torn] even with minimal traction.The procedure was completed using another material." the photo provided depicts a hole in the bottom of the button.The photo received indicates that the tip of the passport is missing.This occurred prior to patient contact; there was no impact to the patient.

Event Description

In preparation for a procedure, the user selected a cook passport low profile gastrostomy device.The patient underwent an attempt to change a gastrostomy device (pass-20-1.7), however, it was not possible because during the traction of the button tip for introduction into the stomach, it [the button] was injured [torn] even with minimal traction.The procedure was completed using another material." the photo provided depicts a hole in the bottom of the button.The photo received indicates that the tip of the passport is missing.Additional information was received on (b)(6) 2019: the red substance in the photo is blood and the device did come in contact with the patient.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.

• Brand Name: PASSPORT LOW PROFILE GASTROSTOMY DEVICE
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8926215
• MDR Text Key: 155552671
• Report Number: 1037905-2019-00491
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002246126
• UDI-Public: (01)00827002246126(17)201002(10)W4144217
• Combination Product (y/n): N
• PMA/PMN Number: K920579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: G24612
• Device Catalogue Number: PASS-20-1.7
• Device Lot Number: W4144217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR