MAUDE Adverse Event Report: COOK INC; KNT TUBES, GASTROINTESTINAL

Catalog Number	WOGS-1400-MKDT-A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt.Identifier) requested but not provided.Age at time of event, date of birth) requested but not provided.Weight) requested but not provided.Ultrathane wills-oglesby single lumen mallinckrodt inst modification gastrostomy set.(b)(4).The event is currently under investigation.
Event or Problem Description
The male patient experienced difficulty when his g-tube was not working.The physician placed a guide to do an exchange/over the wire, and noted that the tube was completely broken about 2 inches from the distal end of the tube.The catheter looked like it had exploded, as it had completely separated while in the patient.A retrieval set was used to retrieve the distal portion of the catheter and no harm was reported to the patient.Another g tube was placed.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device record history, instructions for use (ifu), manufacturing instructions, drawings, quality control,trends and visual inspection of the returned device were conducted during the investigation.The device is shipped with ifu that describes the intended use, specific items are addressed such as warnings, precautions and instructions for placement and use of the device.The manufacturing record for this lot was reviewed, and nothing of note was observed.It should be noted that there are no other complaints of any nature associated with this lot.The visual examination reported the returned device was in two pieces.The hub and cook cope locking mechanism had been cut from the proximal portion of the shaft and were not returned.The distal portion showed the sideports to be produced to specification both in size and alignment.The two pieces were separated and the shaft had inflated at the separation point.We attempted to pass a cook 0.035 wire guide through both portions of the catheter and were able to pass the wire guide through the sections of the tube successfully.The investigation was able to mock up a catheter connected to a syringe at the proximal hub and clamp the distal end of the device with a hemostat.We were able to duplicate the reported event.Based on examination of the returned device and previously conducted experiments, it is reasonable to suggest that the drainage had stopped due to occlusion of the device.In the attempt to clear the obstruction, the catheter was broken and then had to be exchanged and replaced by the physician.Root cause was determined to be related to use and product handling.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The male patient experienced difficulty when his g-tube was not working.The physician placed a guide to do an exchange/over the wire, and noted that the tube was completely broken about 2 inches from the distal end of the tube.The catheter looked like it had exploded, as it had completely separated while in the patient.A retrieval set was used to retrieve the distal portion of the catheter and no harm was reported to the patient.Another g tube was placed.

• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5612203
• Report Number: 1820334-2016-00211
• Device Sequence Number: 13481490
• Product Code: KNT
• UDI-Device Identifier: 00827002084179
• UDI-Public: (01)00827002084179(17)181203(10)6396500
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: WOGS-1400-MKDT-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 07/29/2016
• 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