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U.S. Department of Health and Human Services

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

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COOK INC UNKNOWN; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pleural Effusion (2010)
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 (b)(6) 2014 to (b)(6) 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.Customer (person): postal code: (b)(6), phone: (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.
 
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 one patient developed pleural effusion requiring percutaneous pigtail drainage for 14 days following placement of an unknown 8.3 fr or 10.2 fr internal-external ring biliary catheter."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." of three patients that developed pleural effusions following placement of the device, two patients were treated with conservative management that led to spontaneous resolution.This report captures one patient that required additional pigtail drainage for 14 days.
 
Event Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
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.Standard us and fluoroscopy guided techniques were used to insert a single 8 fr external biliary drainage catheter from another manufacturer, 8.3 or 10.2 fr internal-external ring biliary catheter, or 10 mm diameter zilver self-expanding metallic stent.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.Per the article, five cases had a procedure done from other lobe of liver either due to catheter dislodgement or poor drainage.This investigation will capture one patient experiencing pleural effusion that required percutaneous pigtail drainage for 14 days.Reviews of the documentation, including the complaint history, instructions for use (ifu), manufacturing instructions, and quality control procedures 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 controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) could not be performed, due to the lack of product description and lot information in the article.An expanded sales search was performed for the reported product line shipped to this customer between may2014 and aug2017, but the complaint lot was unable to be identified.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.Evidence gathered from a 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 information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook 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.
 
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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 Key16287627
MDR Text Key308706883
Report Number1820334-2023-00093
Device Sequence Number1
Product Code GBO
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/27/2023
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2023
Initial Date FDA Received02/02/2023
Supplement Dates Manufacturer Received07/24/2023
Supplement Dates FDA Received07/27/2023
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 Number1
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 Age37 YR
Patient SexMale
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