MAUDE Adverse Event Report: COOK INC ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problems Migration (4003); Separation Problem (4043)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: quality associate ii.Pma/510(k) #: not exempt, preamendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the tubing of a ultrathane shetty single lumen gastrojejunostomy set "pulled out past the curly part".It was also reported that the patient has "always had this type of tubing".The patient's wife has stated that the tubing "has red connectors with the number 14 on it".The patient has since had the tube replaced.No other adverse effects to the patient have been reported.Additional information regarding the event and device has been requested but is unavailable at this time.

Event Description

No additional patient/event details have been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6- device code investigation - evaluation it was reported to cook by abbvie incorporated on (b)(6) 2020 that the tubing of a ultrathane shetty single lumen gastrojejunostomy set, rpn: gjs-1400-shetty, was pulled out past the curly part.The device had been in place for over 2 years.Further communication with the user facility clarified that the tube was pulled halfway out and replaced.No adverse effects were reported as a result of this incident.A review of the complaint history, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history files found that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.At this time, cook has concluded that the device was confirmed to specification and that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu for the "shetty gastrojejunostomy set with cope gastrointestinal suture anchor set,¿ provides the following information to the user related to the reported failure mode: instructions for use placement of gastrojejunostomy catheter ¿1.Advance the gastrojejunostomy catheter over the wire and through the sheath.2.Position the locking loop portion of the catheter totally within the pylorus, it may be necessary to peel away the external portion of the sheath.It is essential that the locking loop portion be entirely within the pylorus prior to removal of the peel-away-sheath.5.Pull suture end tight to form a loop configuration in the pylorus and inject contrast to verify catheter tip position within the jejunum.6.Wrap suture around the catheter and secure with a knot, then trim off excess suture and slide the sleeve to prevent leakage.7.Attach the catheter to the skin surface using the physician preferred method of attachment.¿ based on the information provided, no product returned, and the results of the investigation, a root cause was unable to be established.It is possible that the extended length of use for the device contributed to this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information regarding the device was received on 20mar2020.It was reported that the tube itself had no physical damage but was "pulled halfway out".

• Brand Name: ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9793515
• MDR Text Key: 182179629
• Report Number: 1820334-2020-00555
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GJS-1400-SHETTY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention