MAUDE Adverse Event Report: COOK INC

Model Number N/A

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

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: retrospective review of patients from 2014-2019.Suspect medical device: 8.5-10 fr biliary multi-sidehole drainage catheter.Customer (person): postal code: (b)(6).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 adverse event involving an 8.5-10 fr biliary drainage catheter was taken from the following article: henry ac et al., biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage, hpb, https://doi.Org/10.1016/j.Hpb.2021.08.941.The article stated: "patients undergoing pancreatoduodenectomy between january 2014 and december 2019 in the amsterdam umc (location academic medical center) and regional academic cancer center utrecht (location st.Antonius hospital nieuwegein) were identified from existing prospective databases.Included were all consecutive patients undergoing ptbd as a treatment for leakage of the hepaticoje-junostomy or pancreaticojejunostomy.Follow-up was equal to the duration of ptbd (i.E.Biliary drain removal), or to the duration of leakage from a percutaneous intra-abdominal drain (in case of persistent leakage after removal of the biliary drain)." "during the study period, ptbd was routinely placed in patients with 1) a biliary or biliopancreatic leak that did not resolve spontaneously in a few days; and/or 2) severe clinical deterioration/sepsis.Ptbd was always combined with additional percutaneous intra-abdominal catheter drainage with the tip of the drain near the dehiscent anastomosis." "all procedures were performed under deep sedation using propofol or general anesthesia with close monitoring of vital signs.Pre-procedural antibiotic prophylaxis was given if not already administered for the treatment of sepsis.The puncture site was chosen with ultrasound, disinfected and covered with sterile drapes.A local subcutaneous injection of lidocaine could be given.The targeted intrahepatic bile duct was punctured using a 21-gauge needle (chiba tip needle; cook medical, inc., bloomington, ind., usa).The position of the needle was confirmed after injection of contrast medium to visualize the biliary system.In case of very small peripheral bile ducts, the puncture could be performed slightly over and beyond the accompanying left or right portal vein with an appropriate insertion angle of less than 30 degrees between the puncture needle and bile duct running course.While withdrawing the needle, contrast agent was injected until the bile duct is visualized.The target bile duct was chosen based on ultrasound and previously performed ct scan findings, depending on visibility and surrounding vascular anatomy.Once the contrast injection showed that the needle tip was successfully placed in the bile duct, an 0.018 inch cope wire (cook medical, inc., bloomington, usa) was advanced.Over the cope wire, an introducer set was inserted into the central bile duct.Next, an 8 fr vascular access sheath [other manufacturer] was introduced over a stiff wire [other manufacturer].A combination of a 5 fr catheter and a 0.035 inch hydrophilic guidewire [other manufacturer] was then introduced through the sheath to catheterize the jejunal limb.The tip of the catheter can be positioned either towards the pancreaticojejunostomy or distal from the hepaticojejunostomy, towards the gastrojejunostomy.The sideholes in the catheter should be positioned both proximal and distal from the hepaticojejunostomy.Finally, the sheath and catheter were exchanged for a 8.5¿10 fr biliary multi-sidehole drainage catheter (cook medical, inc., bloomington, usa) over a stiff guidewire for external and/or internal drainage.If the jejunal limb could not be reached, a 8.5¿10 fr pigtail catheter was positioned with the tip in the common bile duct.After positioning of the biliary drain, healing of the bile leak could be monitored with repeated cholangiograms, when indicated.Next, the output from intra-abdominal drainage catheters should be monitored: these catheters will produce pancreatic fluid and/or bile in case of a persistent leak." "in addition, 11 patients (17%) suffered from hemorrhagic complications, caused by either hemobilia or ptbd related bleeding that requires an angiographic or surgical intervention." "four patients suffered from a ptbd related bleeding requiring angiographic or surgical intervention (6%)." subject of this report: "in two patients a pseudo-aneurysm of the right hepatic artery was treated with embolization." all hemorrhagic complications are reported under patient identifiers: (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.A total of 2 patients experienced an adverse event, involving the use of a 8.5-10 fr biliary multi-sidehole drainage catheter (rpn: unknown; lot: unknown).The events were reported to cook via the literature article "biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage" (henry et al., 2022).The drain was required for percutaneous transhepatic biliary drainage (ptbd) to treat anastomosis leakage.After the procedure, it was discovered that a pseudo-aneurysm of the right hepatic artery developed in two patients and was treated with embolization.Reviews of the documentation including the complaint history, instructions for use (ifu) and quality control procedures 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 inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) could not be conducted, as the lot was unable to be determined from the literature.Cook also reviewed product labeling.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multiple drainage catheters are intended for percutaneous drainage applications (e.G nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed.References: these instructions for use are based on experience from physicians and (or) their published literature.Refer to your local cook sales representative for information on available literature.Based on the information provided, no returned product and the results of our investigation, it was determined that the root cause of the failure could not be traced to the device.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.

• 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: 13978648
• MDR Text Key: 293834662
• Report Number: 1820334-2022-00517
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2022
• 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: 0.018 INCH COPE WIRE; 0.035 HYDROPHILIC GUIDEWIRE (TERUMO); 21 G CHIBA; 5 FR CATHETER (TERUMO); 8 FR VASCULAR ACCESS SHEATH (CORDIS OR TERUMO); AMPLATZ STIFF WIRE (BOSTON SCIENTIFIC); INTRA-ABDOMINAL DRAINAGE CATHETER
• Patient Outcome(s): Required Intervention