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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

Common device name: gca, catheter, biliary, surgical.(b)(4).The event is currently under investigation.

Event Description

During a ptcd (liver) procedure on a female patient with a tortuous anatomy, the physician got the target the first time.However, it was impossible to remove the stiffener of the ultrathane ring biliary duct drainage catheter so the physician had to remove the whole system and placed a new one.In the second attempt, again the physician couldn't remove the stiffener because it was stuck at the distal tip of the catheter like in the previous attempt.During the attempt to pull it out, the stiffener broke, remaining in the catheter and the biliary duct in the patient's body and it was impossible to remove.The physician got the access again with a lubricated extra stiff wire.With a lot of difficulties and effort, the physician was able to remove the broken catheter and replaced it with a 10.2fr drainage.A section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Common device name: gca, catheter, biliary, diagnostic catheter, nephrostomy.(b)(4).(additional information provided/updated): investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, drawing, instructions for use (ifu), manufacturing instructions, and trends of the product was conducted.The device lot numbers were not reported.Therefore a search of nonconformance data and a search for complaints from the same lot cannot be conducted.The device is packaged with an if; which gives the device description, intended use, contraindications, warnings, precautions and instructions for placement, use and maintenance of the device.The ifu states in step 2, "once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration." without the returned complaint device, the root cause of the customer's difficulty cannot be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

During a ptcd (liver) procedure on a female patient with a tortuous anatomy, the physician got the target the first time.However, it was impossible to remove the stiffener of the ultrathane ring biliary duct drainage catheter so the physician had to remove the whole system and placed a new one.In the second attempt, again the physician couldn't remove the stiffener because it was stuck at the distal tip of the catheter like in the previous attempt.During the attempt to pull it out, the stiffener broke, remaining in the catheter and the biliary duct in the patient's body and it was impossible to remove.The physician got the access again with a lubricated extra stiff wire.With a lot of difficulties and effort, the physician was able to remove the broken catheter and replaced it with a 10.2fr drainage.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5171436
• MDR Text Key: 29063579
• Report Number: 1820334-2015-00677
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• 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: ULT8.5-38-50-P-32S-RING
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2015
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2015
• 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
• Patient Outcome(s): Required Intervention