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

Model Number	G24612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: 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.Per the photograph provided we can see that the end of the bolster was punctured and has a hole in the tip.A small portion of the distal tip appears to be missing.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: "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".Damage to the conical tip may occur if the obturator is advanced further into the device after the conical tip has flattened or if the obturator is off center when the device is elongated for placement.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 the lot said to be involved met all 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 or Problem Description
In preparation for a procedure, the user selected a cook passport low profile gastrostomy device.During an attempt to place the gastrostomy button, the end of the device ruptured, making it impossible to place.The device photo was re-evaluated on 25-june-2018: a small portion of the distal tip appears to be missing.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: PASSPORT LOW PROFILE GASTROSTOMY DEVICE
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7639763
• Report Number: 1037905-2018-00276
• Device Sequence Number: 1861544
• Product Code: KNT
• UDI-Device Identifier: 00827002246126
• UDI-Public: (01)00827002246126(17)190526(10)W3880043
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K920579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: 05/26/2019
• Device Model Number: G24612
• Device Catalogue Number: PASS-20-1.7
• Device Lot Number: W3880043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1