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 Calcified (1077); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as the report date ((b)(6) 2016), no further information has been provided.

Manufacturer Narrative

Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as the report date ((b)(6) 2016), no further information has been provided.

Manufacturer Narrative

Investigation - evaluation: a review of the documentation, instructions for use (ifu), trends and quality control was conducted during the investigation.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.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, user error caused or contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as of the report date (08 sept 2016), no further information has been provided.Additional information received: the nurse stated that "i do not think you need to research this.The surgeon did not know how to work the device.".

• 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: 5936821
• MDR Text Key: 54271279
• Report Number: 1820334-2016-00949
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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: 02/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1