MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: event occurred sometime (b)(6) 2009 to (b)(6) 2016.Common device name: fge, lje.Pma/510(k) #: k173035.(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

The below description of an adverse event using an ultrathane mac-loc locking loop biliary drainage catheter was taken from the following article: tellez-avila et al., ¿biliary drainage in patients with failed ercp: percutaneous versus eus-guided drainage.¿ surgical laparoscopy endoscopy & percutaneous techniques vol.28.3 (june 2018): 183-187.The following is stated in the article: "a total of 90 patients were initially evaluated and 28 were excluded (fig.3).There were 39 (62.9%) women and 23 (37.1%) men, with a median age of 55.6 years (range, 22 to 88 y)." "patients were seen from june 2009 to june 2016 at the national institute of medical sciences and nutrition salvador zubirán at mexico city, mexico" inclusion criteria for the study was "patients with diagnosis of biliary tract obstruction with at least 1 failed ercp procedure or inaccessible second duodenal portion was performed." "etiology of biliary obstruction was malignancy in 35 (56.4%) patients and benign obstruction in 27 patients (43.6%)." "technical success was defined as appropriate placement of 1 stent (plastic or metallic) or biliary catheter drainage into the bile tract by ptbd or egbd.Clinical success was defined as resolution of symptoms that caused the indication of drainage of biliary tract or a decrease in bilirubin by 50% or more in a lapse of 30 days." "we considered complications as follows: perforation was diagnosed when pneumoperitoneum was evident on imaging studies associated with peritoneal signs.Bleeding was defined as any hemorrhagic event that required endotherapy, blood product transfusion, or inpatient observation.Infection was considered if any septic event occurred after the initial drainage (ptbd or eus guided) and was proven by new-onset fever, positive blood cultures, or positive fluid cultures.Stent migration was defined as the need to retrieve a stent from within the biliary tract or the enteral lumen." "a total of 32 patients with 36 procedures underwent percutaneous biliary drainage." "under conscious sedation and with sonographic and fluoroscopic guidance, the dilated right hepatic biliary tree is accessed using a 22-g chiba needle (unknown manufacturer).Initially, a nitinol 0.018-inch guidewire (unknown manufacturer) was passed but was subsequently replaced by a 0.035-inch guidewire (roadrunner pc wire guides with aq hydrophilic coating; cook incorporated, bloomington, in).Over the guidewire, a biliary drainage catheter (ult8.5-38-40-p-32s-clb-rh; cook incorporated) is advanced and deployed in the standard manner." "technical success was achieved in 25/32 (78.1%), and clinical success was achieved in 20/25 (80%) patients." "the average hospital stay was 12.5 days.Complications were observed in 6 (18.7%) patients who presented sepsis, which responded satisfactorily to antimicrobial therapy, 2 more patients (6%) presented intestinal perforation with surgical management and subsequent death of both patients.In the same group of ptbd, 1 patient had an aneurysm of the hepatic artery requiring endovascular management but later died of an embolism.Mortality was 9.4% in this group." medwatch report identified by patient identifier (b)(6) captures the 6 patients in the ptbd group that experienced sepsis (this report).Medwatch report identified by patient identifier (b)(6)captures the first patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the second patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the patient in the ptbd group that experienced an aneurysm of the hepatic artery and subsequent death of an embolism.No other adverse effects were reported for this incident.

Event Description

Medwatch report identified by patient identifier (b)(6) captures the 6 patients in the ptbd group that experienced sepsis (this report).Medwatch report identified by patient identifier (b)(6) captures the biliary drainage catheter used in the first patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the roadrunner wire guide used in the first patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the biliary drainage catheter used in the second patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the roadrunner wire guide used in the second patient in the ptbd group that experienced intestinal perforation and subsequent death.Medwatch report identified by patient identifier (b)(6) captures the patient in the ptbd group that experienced an aneurysm of the hepatic artery and subsequent death of an embolism.

Manufacturer Narrative

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 unknown, unchanged or unavailable.Investigation ¿ evaluation; cook was informed on 14jan2021 of a literature article titled: biliary drainage in patients with failed ercp: percutaneous versus eus-guided drainage (surg laparosc endosc percutan tech, volume 28, number 3, pages 183-187) where the date accepted for publication was 21feb2018.All patients in the article were seen between june 2009 to june 2016 at the national institute of medical sciences and nutrition salvador zubirán in mexico city, mexico.A total of 32 patients with 36 procedures underwent percutaneous biliary drainage.During the procedures, the patients were under conscious sedation with sonographic and fluoroscopic guidance.Using a 22-g chiba needle, the dilated right hepatic biliary tree was accessed.Initially, a nitinol 0.018-inch wire guide was used, but was replaced by a cook 0.035-inch guidewire roadrunner pc wire guides with aq hydrophilic coating [rpn: unknown].Over the wire guide, a cook biliary drainage catheter [rpn: ult8.5-38-40-p-32s-clb-rh] was advanced and deployed in the standard manner.There were complications in six patients with sepsis and they responded satisfactorily to antimicrobial therapy.All lot numbers are unknown.A review of the documentation including the complaint history, instructions for use (ifu), manufacturing instructions and quality control procedures of the product was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no dimensional, visual, or functional verifications could be completed.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) for could not be completed due to lack of lot information from the facility.There is no evidence suggesting nonconforming product exists in house or in the field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿multipurpose drainage catheter¿ [t_multi_rev5], provides the following information to the user related to the reported failure mode: intended use: ¿multipurpose drainage catheters are intended for percutaneous drainage in a verity of drainage applications (e.G., nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.¿ contradictions: ¿bleeding diathesis and uncontrolled hypertension.¿ ¿anticoagulant use.¿ warnings: ¿if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.¿ precautions: ¿a tfe-coated wire guide muse be used with ultrathane catheters.¿ ¿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.¿ 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.¿ based on the information provided, no returned product and the results of our investigation, it was concluded that an adverse event related to the patient¿s condition and/or procedures could have contributed the failure.Sepsis is a systemic infection of the blood stream that results in the activation of the body¿s immune response.It often causes a cluster of symptoms including a drop in blood pressure, increased heart rate, and fever.Sepsis can be mild to severe and can cause patient death if not recognized and treated early.It was reported that the patients who suffered from sepsis were successfully treated with antimicrobial therapy.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 MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• 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 ; 8128294891
• MDR Report Key: 11275043
• MDR Text Key: 233352809
• Report Number: 1820334-2021-00248
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 01/15/2022

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 Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/14/2021; 01/13/2022
• Supplement Dates FDA Received: 02/04/2021; 01/15/2022
• 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: COOK 0.035" ROADRUNNER PC WIREGUIDE; UNKNOWN MANUFACTURER 22-G CHIBA NEEDLE; UNKNOWN MANUFACTURER NITINOL 0.018IN GUIDEWIRE
• Patient Outcome(s): Required Intervention