MAUDE Adverse Event Report: COOK INC ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Customer reported that a patient underwent placement of a ultrathane carey-alzate-coons gastrojejunostomy replacement catheter.The red hub of the device detached at an unspecified time following device placement (mdr#1820334-2017-00767.The patient underwent explant and replacement of the catheter during which the hub of the new catheter detached (mdr# 1820334-2017-00767) when the doctor was pushing the malecot to form the anchor.The forces applied to the device at the time of detachment are not known.No further information was provided.The device was received by the manufacturer for evaluation.This is one of two events reported by the physician.Reference mdr numbers 1820334-2017-00767 and 1820334-2017-00768 for both events.The same patient is associated with both events.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the returned device was performed.The device failure analysis determined that all relevant dimensions are within specification a document based investigation evaluation was also 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.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "while holding the external portion of the catheter with one hand, just proximal to the white suture wing, grasp the suture wing and slide it forward until the black indicator mark on the external portion of the catheter is visible.This will indicate proper expansion of the friction-lock malecot." based on the information provided, examination of the returned device and the results of our investigation it is feasible that the doctor was stabilizing the catheter by holding the red hub instead of positioning his hand just proximal of the white suture wing as required by the ifu.The pressure placed at the hub would likely cause the separation that was seen in consecutive device usage and failure.The root cause is most likely user technique.We will continue to monitor for similar complaints.

• Brand Name: ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6521628
• Report Number: 1820334-2017-00768
• Device Sequence Number: 1594713
• Product Code: KNT
• UDI-Device Identifier: 00827002270442
• UDI-Public: (01)00827002270442(17)200113(10)7588613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-NT-100-P-NS-GJS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1