MAUDE Adverse Event Report: COOK INC ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a pre-amendment product.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient underwent an unspecified surgical procedure with implantation of a wills-oglesby percutaneous gastrostomy catheter on an unknown date.No procedure related details were provided.The patient returned two weeks post procedure with a report that the device had a problem.Examination of the patient and device indicated that the feeding lid was pushing back while in the locked position.The lid portion of the device was removed and replaced with a new lid.No further event or patient details were provided.
Additional Manufacturer Narrative
Investigation included: dimensional verification, review of drawing, review of manufacturer's instructions, review of quality control and visual inspection.The returned wills-oglesby percutaneous gastrostomy catheter was unused, still packaged and the feeding tube was returned in a used condition.There was some biomaterial inside.The customer's wording was unclear, and was taken to mean that it appeared that the feeding lid would slightly push back when attempting to push the plug in, making it look like it was going to open.This was confirmed by attempting to close the tube.The inner diameter of the feeding tube and the distal diameter of the feeding lid plug were measured within specification.It's possible the customer believed the lid should be flush with the tube when fully closed, and the customer's difficulty made it look like the tube was going to open.Another feeding tube adapter was inspected and showed that when fully closed, the lid cannot be flush with the tube.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided and without more information a root cause for the lid to "push back" cannot be determined.We will continue to monitor for similar complaints.

• Brand Name: ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6263681
• Report Number: 1820334-2017-00051
• Device Sequence Number: 849744
• Product Code: KNT
• UDI-Device Identifier: 00827002098916
• UDI-Public: (01)00827002098916(17)190616(10)7049215
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-35-P-12S-WOGS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 06/01/2017
• 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: Required Intervention