MAUDE Adverse Event Report: COOK INC ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
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
It was reported by the international customer that the operator made 2 or 3 attempts to place the feeding tubes using the product; however, air was leaking from the stomach.The procedure was not successful as a result.A computed tomography (ct) scan was performed on the same day as a precaution.The patient elected not to have surgical intervention due to the risks involved, and experienced severe abdominal pain due to the failure of the device.
Additional Manufacturer Narrative
Additional information: 510(k): preamendment.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation, and no issues were found related to the reported issue.The complaint device was requested, along with photos, operating reports, x-rays, and scans.The reporter indicated that none of the aforementioned would be 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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Ifu t cautions that imaging guidance is recommended during product use and to ensure, prior to use, that the gastrostomy device to be used will fit through the lumen of the peel-away sheath.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6834150
• Report Number: 1820334-2017-02623
• Device Sequence Number: 60674
• Product Code: KNT
• UDI-Device Identifier: 00827002344433
• UDI-Public: (01)00827002344433(17)200319(10)7760114
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

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 Model Number: N/A
• Device Catalogue Number: IPSG-M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 01/17/2018
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 01/17/2018; 01/17/2018
• 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
• Patient Age: 72 YR