MAUDE Adverse Event Report: COOK INC UNKNOWN; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported in the abdominal radiology journal article by kumar et al (2021), survival benefit of percutaneous transhepatic biliary drainage for malignant biliary tract obstruction¿a prospective study comparing external and internal drainage techniques, that an unknown 8.3 fr or 10.2 fr internal-external ring biliary catheter experienced dislodgement."after due approval of the institutional ethics committee, a prospective study was conducted to include all consecutive adult patients (18¿80 years) having malignant biliary tract obstruction (mbto) with jaundice due to inoperable gall bladder carcinoma (gbc), cholangiocarcinoma (choca) or periampullary mass (pam) referred to the interventional radiology service and having undergone percutaneous transhepatic biliary drainage (ptbd) from may 2014 to august 2017.The patients with hilar level blocks (mostly due to gbc) had undergone ptbd directly while those with common bile duct (cbd) or ampulla level strictures underwent the procedure if endoscopic retrograde cholangiopancreatography (ercp) failed or in the presence of cholangitis."."the following group of patients were excluded from the study: obstruction due to metastatic nodal mass from other malignances, patients having undergone any prior surgical procedure (except a prior cholecystectomy) involving the pancreatico-hepatobiliary system, international normalized ratio (inr) more than 1.6, platelet count less than 50,000/mm3, indirect bilirubin level more than 10.0 mg/dl, diffuse metastatic hepatic disease, defined as more than 5 separate lesions or any one lesion more than 12 cm in average triplane dimension, cirrhosis, significant medical disease (defined as more than two uncontrolled medical conditions), initial body weight less than 35 kg in females and 45 kg in males, initial hemoglobin level less than 6 gm%, ascites more than 500 ml estimated on ultrasound (us), poor general condition, defined as eastern cooperative oncology group (ecog) performance status grade greater than 2, patients on anticoagulation or dual antiplatelet therapy, biliary radicle obstruction beyond bifurcation of right or left hepatic duct as seen on us and contrast enhanced computerized tomography (cect) scan." "standard us and fluoroscopy guided techniques were used to insert single 8 fr external biliary drainage catheter from another manufacturer, 8.3 or 10.2 fr internal-external ring biliary catheter (cook, bloomington, in, usa) or 10 mm diameter zilver self-expanding metallic stent (cook ireland)."a total of 87 patients underwent a total of 152 procedures with 100% technical success rate.No direct procedure-related death occurred, albeit the 30 days mortality was 6.89% (n = 6), attributable to sepsis, disease progression, or/and liver function deterioration.".It was noted in the article that five cases had the procedure done from the other lobe of the liver, either due to catheter dislodgement or poor drainage.This report will capture three patients that experienced catheter dislodgement.The two other instances of poor drainage will be referenced in the report with patient identifier: (b)(6).

Manufacturer Narrative

Literature citation: kumar, s.Et al (2021).Survival benefit of percutaneous transhepatic biliary drainage for malignant biliary tract obstruction-a prospective study comparing external and internal drainage techniques.Abdominal radiology, 46, 5408-5416.Doi: https://doi.Org/10.1007/s00261-021-03215-4.Date of event: these events occurred between may 2014 to august 2017.Additional common name: fge catheter, biliary, diagnostic; lje catheter, nephrostomy.Additional product code: fge; lje catheter, nephrostomy.Rpn: the device is likely either a ult8.5-38-50-p-ring-25.5-meh-rh or ult10.2-38-50-p-ring-25.5-meh-rh.Initial reporter: customer (person): postal code: (b)(6).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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (annex a) investigation ¿ evaluation it was reported in the abdominal radiology journal article by kumar et al (2021), ¿survival benefit of percutaneous transhepatic biliary drainage for malignant biliary tract obstruction¿a prospective study comparing external and internal drainage techniques¿, that an unknown 8.3 fr or 10.2 fr internal-external ring biliary catheter experienced poor drainage.The article investigates the effectiveness of percutaneous transhepatic biliary drainage (ptbd) in treating malignant biliary tract obstruction.The study involves comparing the survival rates of patients who underwent internal and external drainage techniques for ptbd.Per the article, five cases had a procedure done from other lobe of liver either due to catheter dislodgement or poor drainage.This report will address three cases where the procedure was done from other lobe of liver due to catheter dislodgment.The literature indicates the devices to be a 8.3 or 10.2 fr internal-external ring biliary catheter.However, the likely devices were ult8.5-38-50-p-ring-25.5-meh-rh and /or ult10.2-38-50-p-ring-25.5-meh-rh.Reviews of the instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) could not be performed due to an unknown lot number.Cook medical inc.Performed an expanded sales search for the reported product line shipped to this customer between may 2014 to august 2017.Unfortunately, cook was unable to identify the complaint lot.Cook also reviewed product labeling.Instructions for use (ifu) document [t_multi2_rev1] [multipurpose drainage catheter] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: warnings: ¿ if catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.Precautions: ¿ catheters should be irrigated on a routine basis to ensure function.¿ patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.The information provided upon review of the dmr and ifu 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 limited information provided, no returned device, and the results of the investigation, it was determined the cause of this event is related to a component failure, without any design or manufacturing issue.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

Event Description

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

• Brand Name: UNKNOWN
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 16287776
• MDR Text Key: 308707991
• Report Number: 1820334-2023-00092
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/22/2023
• 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: COOK 5FR SHEATH.; COOK AMPLATZ EXTRASTIFF GUIDEWIRE.; COOK FASCIAL DILATORS.; CORDIS 4FR MPA, C1 OR JR4 CATHETER.; GE BRIVO C-ARM.; GE LOGIQE 18G PUNCTURE NEEDLE.; PHILIPS ALLURA CLARITY DSA MACHINE.; TERUMO 0.035 INCH NITINOL HYDROPHILIC GUIDEWIRE.
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male