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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510k status: preamendment.(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 Description

The international customer reported that when the operator of the ultrathane wills-oglesby percutaneous gastrostomy catheter pulled the locking suture, the catheter was "torn up" [sic].However, the suture reportedly did not break.A new product was then used to continue the procedure, with no further product problems reported.The customer confirmed that this issue occurred prior to any patient contact.Accordingly, no patient adverse events occurred as a result of the event.No further incident information was provided by the customer.The complaint product has been returned for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the manufacturing instructions, specifications, instructions for use (ifu), drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there was a longitudinal split through the catheter at the location of the pigtail that extends from the suture entry hole to the suture exit hole.It was observed that the catheter was split from the points where the suture should enter and exit the catheter lumen.The ifu states "form the catheter loop by applying light traction to the loop string.Gently manipulate the catheter until the loop is clearly free within the gastric lumen.Note: do not withdraw the loop so far that it begins to enter the gastrostomy tract; doing so may result in withdrawal of catheter side holes into the tract, and is not necessary for apposition of the stomach to the abdominal wall.Note: use fluoroscopy to facilitate proper positioning of the catheter loop.Pull suture end tight to form loop configuration in catheter, and tie securely." additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be user error.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7097760
• MDR Text Key: 94222703
• Report Number: 1820334-2017-04321
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-35-P-12S-WOGS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1