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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Internal Organ Perforation (1987); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): 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 "t-fastener/suture anchor" was retained in the patient 11 years after implantation of a ultrathane shetty single lumen gastrojejunostomy device.On (b)(6) 2009, due to undisclosed circumstances, a female patient underwent a procedure in which the shetty gastrojejunostomy device was implanted.The tube was removed in 2010.The patient reported that a "t-fastener or piece of metal from the kit" was left behind in her stomach.The t-fastener is not needing to be removed because it has penetrated the patient's stomach wall and is moving towards her pancreas, based on data obtained from a ct scan.The length of the piece of metal was found to be between 2 and 2.5cm on the ct scan.The patient underwent a procedure on (b)(6) 2020 in an attempt to remove the suture anchor devices.The physician was only able to successfully remove one suture anchor, and the other remains in the patient.Additional information has been requested regarding patient and event details but is currently unavailable.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported to cook that a female patient had an ultrathane shetty single lumen gastrojejunostomy set (rpn: gjs-1400-shetty) implanted on 11nov2009.The tube was removed in 2010.A piece of t-fastener or metal from the kit was left behind in her stomach.It appears to have penetrated her stomach wall and is going toward the pancreas based on a ct scan.On 17nov2020, an attempt to remove the t-fastener/suture anchor devices was made.The physician successfully removed one; however, the second t-fastener/suture anchor remains in the patient.A review of documentation including the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as a review of photos provided, was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, photos of the retrieved suture/anchor from the complainant were supplied.From the photos, the anchor appears to be intact with no parts missing.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) found that product is safe and effective for its intended use.A review of the device history record (dhr) for 2364760 found no nonconformances that could have contributed to the reported failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information related to the reported failure mode: instructions for use: ¿3.Attach a 10 ml syringe, half filled with contrast medium, to the introducer needle that has been preloaded with the suture anchor.5.Remove the 10 ml syringe from the needle hub.While maintaining slight tension on the trailing suture, introduce the distal spring coil 0.035 inch portion of the wire guide into the needle and use it to push the suture anchor out of the needle into the stomach cavity.7.With the wire guide still in position, apply traction to the suture to pull the anterior wall of the stomach against the abdominal wall.8.While maintaining traction on the suture anchor, secure the suture to the skin under slight tension.10.To place the second suture anchor, reintroduce the introducer needle as described in step 4.13.Follow steps 6 through 8 with the second anchor.Note: the suture may be left in place for two weeks while tract formation occurs, or it may be cut after gastrostomy catheter placement.This releases the anchor into the stomach, allowing its passage via the gastrointestinal system.¿ based on the information provided, examination of device photos, and the results of our investigation, it was concluded that a component failure unrelated to design or manufacturing deficiencies contributed to the event.The suture anchors may have been in place for too long and/or may have been excessively tight, these issues could contribute to device migration.However, these potential issues could not be confirmed since no specific date of when the suture was cut is available.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 10977468
• MDR Text Key: 220658990
• Report Number: 1820334-2020-02267
• 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: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Model Number: N/A
• Device Catalogue Number: GJS-1400-SHETTY
• Device Lot Number: 2364760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 TERUMO GUIDEWIRES; DTVN-5.0-19-10.0-YUEH; TERUMO CATHETER
• Patient Outcome(s): Other; Required Intervention