Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
The international customer reported that, when the radiologist attempted to lock the ultrathane mac-loc locking loop biliary drainage catheter into place following placement over the wire, the locking suture snapped at the hub of the device.The device had to be exchanged for another catheter.The customer confirmed that no patient adverse events occurred as a result of the issue.The procedure was a biliary drainage catheter exchange.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
 
Manufacturer Narrative
Additional information: please reference related mfr.Report:1820334-2017-04462.Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device was completed during the investigation.The visual inspection of the returned device confirmed that the black suture string was broken.The string was missing from the locking mechanism.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
 
Event Description
The international customer reported that, when the radiologist attempted to lock the ultrathane mac-loc locking loop biliary drainage catheter into place following placement over the wire, the locking suture snapped at the hub of the device.The device had to be exchanged for another catheter.The customer confirmed that no patient adverse events occurred as a result of the issue.The procedure was a biliary drainage catheter exchange.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.As this case did not involve the suture remaining in the body and did not require a different procedure at another date, it should not have been submitted as reportable and should not reflect a change to cook's handling of similar complaints.As this case did not involve the suture remaining in the body and did not require a different procedure at another date, it should not have been submitted as reportable and should not reflect a change to cook's handling of similar complaints.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7133073
MDR Text Key95824275
Report Number1820334-2017-04463
Device Sequence Number1
Product Code GCA
UDI-Device Identifier00827002094994
UDI-Public(01)00827002094994(17)200706(10)8042440
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberULT12.0-38-40-P-32S-CLB-RH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
-
-