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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The below report of complications with a wills-ogelsby catheter was taken from the following article: odreda, d.Et.Al, ¿safety of outpatient vs inpatient percutaneous radiological gastrostomy tubes in patients with head and neck cancers." canadian association of radiologists journal 67 (2016) 416-419."following institutional research ethics board approvals, the electronic medical records of all head and neck cancer patients who underwent prg from january 2010 to june 2013 were reviewed.In total, 50 ops and 51 ips underwent 101 gastrostomy procedures.The ops were transferred post procedure to the outpatient procedure unit, where the medical or radiation oncology service physician assessed them.If approved by the caring physician, the patient was discharged home to return to the cancer centre the following morning.They were at that time assessed by the integrated cancer team (medical oncology, radiation oncology, and dietician).The ips were admitted prior to the procedure and observed overnight following the procedure.The enteral feeds were started in consultation with a registered dietician the next day, if so required.Previous to 2012, all prgs in head and neck cancer patients were inserted as ips.In early 2012, the practice at our hospital transitioned into a predominantly op prg insertion for head and neck cancer patients." "the purpose of this retrospective study was to investigate the success and complication rates of prg as an op procedure versus ip procedure in head and neck cancer patients.We hypothesized that prg can be successfully performed in an op setting with comparable success and complication rates to an ip setting.Specifically, the 15-day mortality, 15-day early complications, 6-month minor complications, and 6-month major complications were compared between the 2 settings." "complications were categorized into minor or major.Any complication necessitating procedural intervention was classified as major." "all procedures were performed by 1 of 3 fellowship trained interventional radiologists.The patient ingested 125 ml of polibar plus barium solution (.) 12 to 16 hours before the procedure.Alternatively, the barium solution was given via nasogastric tube.Pre-procedure sonographic examination of the abdomen was performed for left liver edge localization.Gastric insufflation was achieved via an existing nasograstric tube or by advancing a 5-f kmp catheter (cook medical, bloomington, in) into the stomach under fluoroscopic guidance via nasal approach.The abdomen was prepped and draped in a sterile fashion.Local anesthesia was administered to the abdominal wall.Conscious sedation was administered using a combination of intravenous midazolam and fentanyl.The access site was localized via fluoroscopic examination of the insufflated stomach.Depending on operator preference, 1 or 2 t-fastener gastropexy sutures (cook medical) were placed percutaneously to bring the anterior stomach wall into contact with the anterior abdominal wall.An 18-gauge needle was used to access the gastric lumen.Placement was confirmed with air aspiration and contrast injection.A 0.035 amplatz guidewire (.) was advanced through the needle into the stomach, the needle was withdrawn and the tract dilated.A 12-f wills-oglesby gastrostomy tube (cook medical) was advanced into the stomach over the wire and the wire was withdrawn.The pigtail locking mechanism was deployed and contrast was injected via the tube for final placement confirmation.Catheters were fixated to the skin with a stat-lock device (.).Prophylactic antibiotics were not administered.For ips, tubes were not used for 24 hours following placement.Physician assessment for signs of peritonitis was performed before initiation of g-tube feeds.For op procedures, the patient recovered in a monitored area for 4- 6 hours.One liter of normal saline was infused intravenously over 4 hours to ensure proper hydration.The patient was discharged home after physician examination and returned to hospital the following morning for repeat physician assessment before initiation of oral or g-tube feeds." table 1 and table 4 detail several patients experiencing major and minor malfunctions following catheter placement.This report captures seven patient that experienced minor complications involving dislodgement of the wills-ogelsby catheter.Related reports capturing complications are reported under patient identifiers: (b)(6).

Manufacturer Narrative

Investigation ¿ evaluation.On (b)(6) 2021, cook medical received a complaint from a representative at the (b)(6) hospital, located in the city of (b)(6), ca."following institutional research ethics board approvals, the electronic medical records of all head and neck cancer patients who underwent prg from (b)(6) 2010 to (b)(6) 2013 were reviewed.In total, (b)(4)." ¿all procedures were performed by 1 of 3 fellowship trained interventional radiologists.The patient ingested 125 ml of polibar plus barium solution ((b)(4), milan) 12 to 16 hours before the procedure.Alternatively, the barium solution was given via nasogastric tube.Pre-procedure sonographic examination of the abdomen was performed for left liver edge localization.Gastric insufflation was achieved via an existing nasograstric tube or by advancing a 5-f kmp catheter (cook medical, (b)(6), in) into the stomach under fluoroscopic guidance via nasal approach.The abdomen was prepped and draped in a sterile fashion.Local anesthesia was administered to the abdominal wall.Conscious sedation was administered using a combination of intravenous midazolam and fentanyl.The access site was localized via fluoroscopic examination of the insufflated stomach.Depending on operator preference, 1 or 2 t-fastener gastropexy sutures (cook medical) were placed percutaneously to bring the anterior stomach wall into contact with the anterior abdominal wall.An 18-gauge needle was used to access the gastric lumen.Placement was confirmed with air aspiration and contrast injection.A 0.035 amplatz guidewire (boston scientific, (b)(6), ma) was advanced through the needle into the stomach, the needle was withdrawn and the tract dilated.A 12-f wills oglesby gastrostomy tube (cook medical) was advanced into the stomach over the wire and the wire was withdrawn.The pigtail locking mechanism was deployed and contrast was injected via the tube for final placement confirmation.Catheters were fixated to the skin with a stat-lock device ((b)(6), ga).Prophylactic antibiotics were not administered.For ips, tubes were not used for 24 hours following placement.Physician assessment for signs of peritonitis was performed before initiation of g-tube feeds.For op procedures, the patient recovered in a monitored area for 4-6 hours.One liter of normal saline was infused intravenously over 4 hours to ensure proper hydration.The patient was discharged home after physician examination and returned to hospital the following morning for repeat physician assessment before initiation of oral or g-tube feeds.¿ reviews of the documentation including the instructions for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.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 device history record (dhr) was unable to be conducted due to the lack of lot information.Cook also reviewed product labeling.The product ifu, [t_wpg_rev10] ¿wills-oglesby percutaneous gastrostomy set,¿ provides the following information to the user related to the reported failure mode: instructions for use: ¿11.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 the it begins to enter the gastrostomy tract; doing so may result in the withdrawal of catheter sideholes 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.12.Pull suture end tight to form loop configuration in catheter, and tie securely.13.Trim off excess suture, and slide latex sleeve over suture to prevent leakage.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, ifu, and design history file, suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.The appropriate personnel have been notified.Per the 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 WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12591326
• MDR Text Key: 276696086
• Report Number: 1820334-2021-02290
• 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: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 1-2 COOK T-FASTENER GASTROPEXY SUTURES.; BARD MEDICAL STAT-LOCK DEVICE.; BOSTON SCIENTIFIC 0.035 AMPLATZ GUIDEWIRE.; COOK 5-F KMP CATHETER.