| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problem
Inflammation (1932)
|
| Event Date 01/22/2020 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Date of event: event occurred sometime between january 2011 and june2017 suspected medical device: ultrathane biliary drainage catheter, 7fr product code: gbo, fge, or lje.Reporter occupation: unknown.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 biliary drainage catheter was taken from the following article: ba yongjiang et al., ¿percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma.¿ endoscopy international open vol.8 (2020): 203-210.The article mentions the cook 7fr catheters were used for internal-external and external percutaneous biliary puncture drainage procedures.Although the exact product information cannot determined, the product is likely an ultrathane biliary drainage catheter.The following is stated in the article: "between january 2011 and june2017, a total of 180 patients with ii, iii, and iv hc were enrolled in this retrospective cohort study.According to the drainage method, patients were divided into two groups: ptbd (n = 81) and ercp (n = 99)." "patient demographics, including age and sex, and biochemistry, including tumor marker ca19 ¿ 9, white blood cell (wbc) count, serum amylase level, and electrolytes were collected before the drainage procedure.Total bilirubin (tbil) level, wbc, serum amylase, and electrolyte levels were checked again at 24 and 48 hours and 1 and 2 weeks after biliary drainage.Data on body temperature, color of bile, and abdominal pain score (evaluated by numerical rating scale [nrs]) were also recorded." for the patients in the ptbd group: "the dilated intrahepatic bile duct of the expected retention liver was selected based on imaging findings.Ultrasound or x-ray guided percutaneous transhepatic cholangiography was achieved by using a trocar to penetrate the target intrahepatic bile duct.The guidewire was then advanced through the trocar to lead the tube insertion.After the guidewire passed over the malignant stenosis site and the duodenal papilla, a catheter (7fr; (¿.Cook or another manufacturer.)) was placed with its distal end along the guidewire in the duodenum for internal-external drainage.Ptbd external drainage was performed if the guidewire failed to pass the malignant stenosis site of the intrahepatic bile duct.¿ ¿forty-nine of the 81 patients in the ptbd group had external drainage with the catheter tip left above the obstruction and 32 had internal-external drainage with the tip of the catheter in the duodenum.¿ "complications, including acute cholangitis, pancreatitis, and hemobilia, were recorded [9].Diagnostic criteria for acute cholangitis were based on the tg13 tokyo guidelines and included: (1) upper abdominal pain (nrs= 4); (2) fever (> 38.0¿) and/or chills; (3)serum total bilirubin (tbil) level > 34.2 ¿mol/l; and (4) inflammatory response (wbc> 10,000/¿l, crp>1mg/dl) [10].The revised atlanta classification of acute pancreatitis was used to assess: (1) abdominal pain (nrs > 4) > 24 hours after drainage; (2) amylase level more than three times normal level; and (3) gastrointestinal perforation, acute cholecystitis or acute peritonitis [11].Clinical diagnosis of hemobilia consisted of: (1) blood mixed with bile after biliary drainage; (2) slight bleeding indicated by a small amount of black stool or positive occult blood test; and (3) moderate to severe bleeding, indicated by a drop in hemoglobin of 3 g/l, requiring blood transfusion, angiographic intervention, or surgery [12, 13].Successful drainage was defined as a reduction in serum bilirubin level to <50% of the pre-drainage value within 2 weeks or normalization after the procedure without any complications during the follow-up period [14]." "fifty-five of 180 patients (30.56 %) developed post-drainage cholangitis: 37 in the ercp group and 18 in the ptbd group.Among them, 46 cases (83.64 %) of post-procedure acute cholangitis were considered as bacterial contamination originating from the duodenum, eight cases (14.55 %) with drainage tube migration and 1 case (1.81 %) with blockage of drainage tube caused by hemobilia.Most fevers occurred within 24 hours after intervention." "nineteen of 180 patients (10.56%) developed post-procedure pancreatitis, with significantly more patients in the ercp group than in the ptbd group (17 [17.17%] vs.2 [2.47%], p = 0.001)." "four of 180 patients (2.22%) had hemobilia, and there was no statistical difference between the two groups (2.02% in ercp group vs.2.47% in ptbd group, p = 0.76)." medwatch report identified by patient identifier (b)(6) captures the 9 patients in the ptbd group who developed cholangitis.(this report) medwatch report identified by patient identifier (b)(6) captures the 2 patients in the ptbd group who developed hemobilia.Medwatch report identified by patient identifier (b)(6) captures the 2 patients in the ptbd group who developed pancreatitis.Medwatch report identified by patient identifier (b)(6) captures the 8 patients in the ptbd group who developed cholangitis with drainage tube migration.Medwatch report identified by patient identifier (b)(6) captures the 1 patient in the ptbd group who developed cholangitis with blockage of drainage tube caused by hemobilia.Per the article, no other adverse effects were reported for these incidences.
|
| |
|
Manufacturer Narrative
|
|
Investigation ¿ evaluation: a journal article by ba yongjiang et al.Called ¿percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma¿ in endoscopy international open vol.8 (2020): 203-210 reported that 9 patients developed post-procedure cholangitis after an unknown 7fr cook drainage catheter was placed for percutaneous biliary drainage.The procedures were performed over the span of several years at various institutions.The cholangitis reportedly developed after the drainage tube became occluded due to hemobilia or after the drainage tubes migrated.The article did not provide information regarding the patient's outcome other than "most fevers occurred within 24 hours after intervention." a review of the complaint history, instructions for use (ifu), and quality control 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.The article mentions the cook 7fr catheters were used for internal-external and external percutaneous biliary puncture drainage procedures.Cook inc.Does not make 7fr biliary drainage catheters (rpn: %-clb-%).It is possible that a multipurpose drainage catheter was used for biliary puncture.Cook inc.Manufactures several kinds of multipurpose drainage catheters, most popular being the ult%.Cook reviewed the current quality control inspections for ult catheters and there are currently appropriate inspections in place to verify the catheter lumen, sideports, and surface and ensure the locking mechanism is effective.Cook cannot review the products' specific labeling or instructions for use due to lack of product information.The current instructions for use for most ult drainage catheters states the following: "warnings: if a 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.How supplied: -supplied sterilized by ethylene oxide 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.¿ the current instructions for use also provide specific placement instructions for the various types of locking mechanisms.The article does not provide rpn or lot information, only stating the devices are 7.0fr catheters.The article lists 11 implant facilities, but does not specify which procedures occurred at which facility, so cook is unable to review the device history record.Based on the provided information, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.It is unknown if drainage tube migration or occlusion, catheter misplacement, improper maintenance, or the patient's preexisting conditions contributed to cholangitis.Based on the information included in the article, no returned product, and the results of the investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.
|
| |
|
Search Alerts/Recalls
|
|
