MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Event Description

After biliary drainage tube placement surgery on the (b)(6) male patient, it was noted that the joint of the catheter was leaking bile.An examination of the catheter and the joint portion found a crack in the material.This was replaced with a new device.The patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(6).Investigation - evaluation: a review of drawings, device history record, instructions for use (ifu), manufacturing instructions, specifications and quality control was conducted during the investigation.The device is shipped with an instruction for use; which provides instructions for insertion and removal as well as applicable warning and precautions.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Action has been previously initiated to further investigate this failure.We will continue to monitor for similar complaints.Per the health risk assessment (hra) no further action is required.

Event Description

After biliary drainage tube placement surgery on the (b)(6) male patient, it was noted that the joint of the catheter was leaking bile.An examination of the catheter and the joint portion found a crack in the material.This was replaced with a new device.The patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY 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: 5808445
• MDR Text Key: 49974521
• Report Number: 1820334-2016-00636
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)190219(10)6748071
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Date Device Manufactured: 02/19/2016
• 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 Age: 60 YR
• Patient Weight: 70