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COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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| Model Number N/A |
| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problems
Death (1802); Perforation (2001); No Code Available (3191)
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| Event Date 02/21/2018 |
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Event Type
Death
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Manufacturer Narrative
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Date of event: event occurred sometime june 2009 to june 2016.Additional common device name: lje, fge.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.
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Event Description
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The below description of an adverse event 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 article mentions cook 8.5fr biliary drainage catheter and cook 0.035-in roadrunner pc wire guides with aq hydrophilic coating were used for percutaneous biliary puncture drainage procedures.It is unknown which device was involved in this incident.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" "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.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 (this report).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.No other adverse effects were reported for this incident.
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Manufacturer Narrative
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Investigation ¿ evaluation.Cook was informed 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 (b)(6) 2009 to (b)(6) 2016 at the national institute of medical sciences and nutrition salvador zubirán in mexico city, mexico.A total of (b)(4) patients with (b)(4) 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.Two patients had intestinal perforation with surgical management that resulted in two patient deaths.This investigation captures one patient involving the ultrathane mac-loc locking loop biliary drainage catheter [rpn: ult8.5-38-40-p-32s-clb-rh].The lot number is unknown.A review of documentation including the instructions for use (ifu), manufacturing instructions, and quality control inspections of the device were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.Based on the known information, there is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.A document based investigation evaluation was performed.A device master record (dmr) review was performed, and device manufacturing instructions and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for biocompatibility testing.The device is shipped with instruction for use (ifu) which 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.¿ contradicitons: -¿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.¿ a review of the device history record (dhr) could not be conducted due to lack of lot information from the user facility.In the article, the patients were seen between (b)(6) 2009 to (b)(6) 2016 at the national institute of medical sciences and nutrition salvador zubirán in mexico city, mexico.Therefore, a global sales shipment report was conducted from (b)(6) 2006 through (b)(6) 2016 for rpn: ult8.5-38-40-p-32s-clb-rh.Cook was unable to narrow down the lot this complaint pertains to.There is no evidence suggesting nonconforming product exists in house or in the field.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.It was reported that the patient presented intestinal perforation with surgical management and subsequent death after the ptbd procedure was performed.Gastrointestinal perforation is also known as a ruptured bowel.This happens when a hole in the wall of part of the gastrointestinal tract occur.Gastrointestinal perforation is an inherent risk with the ptbd procedure especially with the use of a wire guide.No information regarding the patient¿s anatomy was provided.It is possible that due to patient anatomy or inadvertent user error the device and/or concomitant products were manipulated in a way that caused a gastrointestinal perforation to occur.Based on the limited information included in the article and the results of the investigation, it was concluded this was an adverse event related to the patient¿s condition and/or the procedure.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.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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