MAUDE Adverse Event Report: COOK INC RING BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/22/2020

Event Type  Injury  

Event Description

The following adverse event following placement of 8.3 fr cook ring biliary catheter comes from the following article: behera, r.K., srivastava, d.N., kumar, p., et al."right-sided versus left-sided percutaneous transhepatic biliary drainage in the management of malignant biliary obstruction: a randomized controlled study." abdominal radiology (2021) 46:768¿775."fifty patients (28 males, 22 females; mean age 51.78 years) with mbo were randomized to undergo either rptbd or lptbd during the study period between june 2016 and may 2018.The procedure time, fluoroscopy time, radiation doses to the operators and patients, technical success, clinical success, complications and effect on quality of life were evaluated and compared between the two groups." "the procedure was performed using a combination of usg and fluoroscopy imaging under local anesthesia.Due to the high volumes and the difficulty in having round the clock service of an anesthesiologist in the interventional radiology suite, procedures were performed without sedation.Initial ductal puncture was achieved using usg guidance with an 18g needle in all patients; subsequent steps were done under fluoroscopy.Fluoroscopy was performed on the allura xper xd40 [competitor manufacturer] angiography machine.A pocket radiation dosimeter [competitor manufacturer] was worn on the wrist of the primary radiologist performing the procedure for measuring the radiation dose to the operator.Anterior subxiphoid approach was used for the left-sided ptbd (lptbd) and right lateral intercostal approach, below the 10th rib, was used for the right-sided ptbd (rptbd).After the initial puncture, cholangiogram was performed to assess the site of obstruction.Then, attempt was made to cross the obstruction with an angled soft 0.035 inch hydrophilic guide wire.When the stricture was crossed, an 8.3f ring biliary catheter (cook medical, bloomington, usa) was inserted over a stiff guide wire for internal/external drainage (fig. 1).The external end of the ring biliary catheter was capped after 3 days of inter-nalization.Otherwise, an 8f pigtail catheter was placed and internalization was attempted a week later.The catheter was secured to the skin with sutures in all patients." "the study group consisted of 50 patients (25 each in the rptbd and lptbd groups).There were 22 females (44%) and 28 males (56%) and the mean age of the patients was 51.78 ± 12.35 (28¿83) years.The baseline patient characteristics including age, sex, pre-procedure total bilirubin levels, ecog scores and etiologies in the two groups are shown in table 1." "major complications were seen in a total of four patients and minor complications in 18 patients.No procedure-related death was seen in either group." table 2 shows self-limiting hemorrhage [mean time of presentation 2 (1-3) hours] in 2 patients with rptbd and in 3 patient with lptbd.Minor self-limiting hemorrhage was observed in five patients (10%), with two in rptbd (8%) and three in lptbd (12%) groups (p = 0.637).Three out of the five patients required overnight clamping of the catheter.None had major hemorrhage.This report captures all 5 patients with self-limiting hemorrhage.

Manufacturer Narrative

Customer contact details: phone: (b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation on 28mar2022, cook medical was notified of a journal article by rajendra kumar behera et al, "right-sided versus left-sided percutaneous transhepatic biliary drainage in the management of malignant biliary obstruction".This article was published 22jul2020, https://doi.Org/10.1007/s00261-020-02651-y.The following information provides a detailed explanation of the study: ptbd procedure: the procedure was performed using a combination of usg and fluoroscopy imaging under local anesthesia.Due to the high volumes and the difficulty in having round the clock service of an anesthesiologist in the interventional radiology suite, procedures were performed without sedation.Initial ductal puncture was achieved using usg guidance with an 18g needle in all patients; subsequent steps were done under fluoroscopy.Fluoroscopy was performed on the allura xper xd40 (phililps, netherlands) angiography machine.A pocket radiation dosimeter (mydose mini, hitachi aloka, japan) was worn on the wrist of the primary radiologist performing the procedure for measuring the radiation dose to the operator.Anterior subxiphoid approach was used for the left-sided ptbd (lptbd) and right lateral intercostal approach, below the 10th rib, was used for the right-sided ptbd (rptbd).After the initial puncture, cholangiogram was performed to assess the site of obstruction.Then, attempt was made to cross the obstruction with an angled soft 0.035 inch hydrophilic guide wire.When the stricture was crossed, an 8.3f ring biliary catheter (cook medical, bloomington, usa) was inserted over a stiff guide wire for internal/external drainage (fig.1).The external end of the ring biliary catheter was capped after 3 days of internalization.Otherwise, an 8f pigtail catheter was placed and internalization was attempted a week later.The catheter was secured to the skin with sutures in all patients.The study group consisted of 50 patients (25 each in the rptbd and lptbd groups).There were 22 females (44%) and 28 males (56%) and the mean age of the patients was 51.78 ± 12.35 (28¿83) years.The baseline patient characteristics including age, sex, pre-procedure total bilirubin levels, ecog scores and etiologies in the two groups are shown in table 1.Major complications were seen in a total of four patients and minor complications in 18 patients.No procedure-related death was seen in either group.Table 2 shows self-limiting hemorrhage; mean time of presentation 2 (1-3) hours in 2 patients with rptbd and in 3 patient with lptbd.Minor self-limiting hemorrhage was observed in five patients (10%), with two in rptbd (8%) and three in lptbd (12%) groups (p = 0.637).Three out of the five patients required overnight clamping of the catheter.None had major hemorrhage.This investigation captures all 5 patients with self-limiting hemorrhage.Reviews of the documentation, including the instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be completed.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 nonconforming product prior to release.A review of the device history record (dhr) for could not be conducted due to the lack of lot information provided in the article.Cook medical inc.Performed an expanded sales search for the reported product line shipped to this customer between 01june2016 through 31may2018.Unfortunately, cook medical was unable to identify the complaint lot.At this time, cook cannot conclude that the device was manufactured out of specification.Since potential nonconformances or other complaints from the device lot cannot be confirmed, there is no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi2_rev1 [multipurpose drainage catheter] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: warnings: if 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.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: RING BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• 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: 14121957
• MDR Text Key: 290160293
• Report Number: 1820334-2022-00593
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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: 01/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ANGLED SOFT 0.035 INCH HYDROPHILIC GUIDE WIRE; HITACHI MYDOSE MINI; PHILILPS ALLURA XPER XD40
• Patient Outcome(s): Required Intervention