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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
Company medical device sales representative reported that a ultrathane carey-alzate-coons double lumen gastrojejunostomy catheter was being used for demonstration and teaching purposes.The device malecot was opened and closed approximately six (6) cycles after which the suture wing disconnected from the malecot.This rendered the device unusable.There was no patient contact, and accordingly no adverse patient consequences.The device is available for evaluation however it was not received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, functional testing and visual inspection of the returned device was conducted during the investigation.One ultrathane carey-alzate-coons double lumen gastrojejunostomy catheter was returned in an open and used condition.No biomatter was present.No visible damage or bends were observed.The malecot was in partially open position.Suture wing was pushed forward to be just in front of the black marker band and malecot stayed in fully open position on its own.The malecot would not close fully when the suture wing was pulled back.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 one nonconforming event which could contribute to this failure mode.The non-conforming device was scrapped.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, functional testing and visual inspection of the returned device was conducted during the investigation.One ultrathane carey-alzate-coons double lumen gastrojejunostomy catheter was returned in an open and used condition.No biomatter was present.No visible damage or bends were observed.The malecot was in partially open position.Suture wing was pushed forward to be just in front of the black marker band and malecot stayed in fully open position on its own.The malecot would not close fully when the suture wing was pulled back.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 one nonconforming event which could contribute to this failure mode.The non-conforming device was scrapped.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.

• Brand Name: ULTRATHANE CAREY-ALZATE-COONS DOUBLE LUMEN GASTROJEJUNOSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6521697
• Report Number: 1820334-2017-00774
• Device Sequence Number: 14891
• Product Code: KNT
• UDI-Device Identifier: 00827002270473
• UDI-Public: (01)00827002270473(17)200120(10)7609259
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: Other
• Device Model Number: N/A
• Device Catalogue Number: ULT16.5D-NT-80-P-2S-GJS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1