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 Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: event occurred sometime "from september 1991 to january 2019." suspect medical device: ult14.0-38-40-p-32s-clb-rh or ult14.0-38-50-p-32s-clb-rh.Additional procodes: fge, lje.Pma/510(k) #: k173035.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 a serious injury using an ultrathane mac-loc locking loop biliary drainage catheter was taken from the following article: bonnel et al., ¿percutaneous biliary external-internal drainage for malignant obstruction of self-expanding uncovered metal stents placed for hilar carcinoma: retrospective analysis of long-term outcome in 160 patients.¿ journal of clinical interventional radiology 4.1 (2020): 3-8.The following was stated in the article: "from september 1991 to january 2019, 160 patients (100 men and 60 women; median: 69 [range: 37¿87] years) with malignant obstruction of multilobar seumss (self-expanding uncovered metal stents) were treated by percutaneous transhepatic external¿internal biliary drainage.All patients were followed in their respective oncology services where they were treated (or not) according to local protocols adapted to their disease and overall general status." 'all patients were hospitalized on the day of the procedure, which was performed under general anesthesia (neuroleptic analgesia).The patient was positioned supine, with the operator on the right, left, or successively on both sides according to the side of the bile duct drainage.The skin was prepared with 10% povidone-iodine solution (.) and was draped accordingly to the planned transhepatic drainage.Single-dose first-generation -lactam cephalosporin (cefazolin 2 g) was administered intravenously at anesthetic induction." because all the 160 patients had multiple entangled metallic meshes in the hilar region, the following steps were performed successively: percutaneous transhepatic cholangiography to determine the level of obstruction.Insertion of hydrophilic guidewires (fig.2) (.) followed by insertion of coaxial dilatators (.) and angioplasty balloons (.), and, finally, insertion of 14f internal¿external biliary drain (fig.3a, b) (14f biliary drainage catheter, cook inc.) to restore biliary patency.Once the 14f internal¿external biliary drain(s) were placed, they were allowed to drain by dependency during 3 days.The drains were then clamped and the external segment was left under a simple dressing.One or more drains were inserted according to whether left/right communication was patent or not.Patients were allowed to leave the hospital on day 5 in the absence of recurrent sepsis or leakage around the drain." "the drains were changed prophylactically every 4 to 6 weeks to avoid plugging and recurrent cholangitis, under general anesthesia in an ambulatory unit." "late complications were observed in 29 (18%) patients." "external¿internal biliary drainage was successful in all 160 patients.All patients were discharged within 5 days.Both immediate (4 patients; 2.5%) and late complications (29 patients; 18%) were managed successfully with minimal morbidity and no mortality.After reestablishment of adequate bile flow, the median survival was 191 days (range: 2¿5,668 days).Forty-one (25.6%) patients survived for more than 12 months, and 10 (6.2%) survived for more than 3 years." "in our series, 29 (18%) patients required 38 rehospitalizations for drainage problems.Of note, a nonoperative solution was found for all patients with early or late complications, even in the case of bleeding (percutaneous embolization) or acalculous acute cholecystitis (percutaneous cholecystostomy).This attests to the safety of the procedure.All deaths in our series were due to on-going disease, not the palliative procedure." this report focuses on the following late complication: "two patients had portal venous bleeding exteriorized by their drain when the drain eroded a portal vessel requiring repositioning of the drain to remove the lateral hole from the portodrain communication." no other adverse effects were reported for this incident.

Manufacturer Narrative

Correction: h6 - annex a.Investigation ¿ evaluation.Cook medical was notified of an incident from a 2020 journal article by bonnel et.Al "percutaneous biliary external-internal drainage for malignant obstruction of self-expanding uncovered metal stents placed for hilar carcinoma: retrospective analysis of long-term outcome in 160 patients." the patients received treatment from (b)(6) 1991 to (b)(6) 2019.This study consisted of 160 patients (100 men and 60 women; median: 69 [range: 37¿87] years) with malignant obstruction of multilobar seumss that were treated by percutaneous transhepatic external¿ internal biliary drainage.All patients were followed in their respective oncology services where they were treated (or not) according to local protocols adapted to their disease and overall general status.All patients were hospitalized on the day of the procedure, which was performed under general anesthesia (neuroleptic analgesia).The patient was positioned supine, with the operator on the right, left, or successively on both sides according to the side of the bile duct drainage.The skin was prepared with 10% povidone-iodine solution (betadine, pfizer) and was draped accordingly to the planned transhepatic drainage.Single-dose first-generation -lactam cephalosporin (cefazolin 2 g) was administered intravenously at anesthetic induction.Because all the 160 patients had multiple entangled metallic meshes in the hilar region, the following steps were performed successively: percutaneous transhepatic cholangiography to determine the level of obstruction.Insertion of hydrophilic guidewires (radifocus guidewire m 0.035 [0.89 mm], terumo corporation) followed by insertion of coaxial dilatators (8/10 dilatator/sheath set, boston scientific) and angioplasty balloons (mars pta-balloon catheter, optimed inc.), and, finally, insertion of a cook 14f internal¿external biliary drain to restore biliary patency.Once the cook 14fr internal¿external biliary drain(s) were placed, they were allowed to drain by dependency over 3 days.The drains were then clamped and the external segment was left under a simple dressing.One or more drains were inserted according to whether left/right communication was patent or not.The patients were allowed to leave the hospital on day 5 in the absence of recurrent sepsis or leakage around the drain.The drains were changed prophylactically every 4 to 6 weeks to avoid plugging and recurrent cholangitis, under general anesthesia in an ambulatory unit.This investigation focuses on the following late complication of two patients developing portal venous bleeding exteriorized by their drain when the drain eroded a portal vessel, requiring repositioning of the drain to remove the lateral hole from the portal drain communication.Reviews of the documentation including the drawing, 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 controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) could not be completed due to the lack of lot information.Cook was unable to perform an expanded sales search for the complaint device.Since potential nonconformances or other complaints from the device lot cannot be confirmed, there is no evidence that the device was manufactured out of specification or that nonconforming product exists in house or in the field.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi_rev5 [multipurpose drainage catheter] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: precautions: ¿ it is recommended to use a wire guide when removing a locking loop catheter.Unlocking catheter loop for mac-loc locking loop mechanism: a.While stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.B.Pry upward until the locking cam level is free.(fig.6) note: for catheter exchange, advance the distal end of a wire guide into the locked loop configuration of the catheter before unlocking the mac-loc assembly.Release the mac-loc as described above.Advance the wire guide through the catheter end hole.Catheter exchange can now be performed.¿ how supplied: ¿ 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, 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.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 ; 8123392235
• MDR Report Key: 13558765
• MDR Text Key: 286867138
• Report Number: 1820334-2022-00254
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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?: 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: 02/09/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/10/2022
• 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: 10% POVIDONE-IODINE SOLUTION, PFIZER.; 8/10 DILATOR SET, BOSTON SCIENTIFIC.; PTA-BALLOON, OPTIMED.; RADIFOCUS GUIDEWIRE 0.035, TERUMO.
• Patient Outcome(s): Required Intervention