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 Obstruction of Flow (2423)

Patient Problem Inflammation (1932)

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 recurrent cholangitis due to drain obstruction that required an early drain change." no other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation.Cook medical was notified of the journal article ¿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¿ by bonnel et al.The study reported complications with unknown cook 14fr biliary drainage catheters.This study consisted of 160 patients with malignant obstruction of multilobar seumss were treated by percutaneous transhepatic external¿ internal biliary drainage.The study covered patients receiving treatment between september 1991 to january 2019.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 14f internal¿external biliary drain (cook medical) to restore biliary patency.Once the 14fr 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.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.Late complications were observed in 29 (18%) patients.These late complications led to 38 rehospitalizations.This complaint focuses on the late complications involving two patients, having recurrent cholangitis due to drain obstruction, requiring an early drain change.A review of the drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures 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.Cook reviewed the current manufacturing controls in place for 14fr biliary drainage catheters, and concluded there are appropriate inspections related to the failure of occlusion.Since the journal article did not provide specific product information, the device history record was not reviewed.Based on the provided information, there is no indication the devices were manufactured out of specification.There is no evidence of nonconforming material in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: it is recommended to use a wire guide when removing a locking loop catheter.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.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.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots.It is unknown whether the catheters were irrigated on a routine basis per the instructions for use.It is unknown whether the patients' condition or procedural technique contributed to the reported catheter occlusions.Based on the limited information in the article, the complaint device not being returned, and the results of the investigation, a definitive cause could not be established.The appropriate internal 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.

Event Description

No additional information regarding the patient and/or event 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: 13552438
• MDR Text Key: 286867446
• Report Number: 1820334-2022-00251
• 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: 05/09/2022

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: 02/17/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/09/2022
• 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