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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK RENEGADE?; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC - CORK RENEGADE?; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number M001182480
Device Problems Component Missing (2306); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2014
Event Type  malfunction  
Event Description
Same case as: 2134265-2014-06005.It was reported that catheter coating was not intact.During a bleeding embolization procedure, a 105/3.0/2.5/.021/20 renegade¿ catheter was selected to treat the target lesion.It was noted that the distal part of the catheter was not fully coated, so they could not put it in the angiography catheter.Another of the same 105/3.0/2.5/.021/20 renegade¿catheter was selected and the same issue occurred.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.During visual examination, no issues were found upon inspection of the catheter under the strain relief for any kinks/breaks in the shaft.The catheter was inspected by rotating the shaft 360° for any kinks/bumps/damage along the shaft.No kinks or bumps were noted.However, it was observed that the coating felt thinner on the distal end of the shaft.A mandrel was advanced through the returned device ¿ blood blocked the catheter.This is an indication that a continuous flush was not maintained throughout the procedure.A flush could not be performed due to this.Coating confirmation test was performed using crystal violet solution.Damaged and missing coated was present on the distal end of the catheter.Damaged coating can be depicted from black shiny marks present on the catheter post crystal violet coating confirmation test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
Same case as: 2134265-2014-06005.It was reported that catheter coating was not intact.During a bleeding embolization procedure, a 105/3.0/2.5/.021/20 renegade¿ catheter was selected to treat the target lesion.It was noted that the distal part of the catheter was not fully coated, so they could not put it in the angiography catheter.Another of the same 105/3.0/2.5/.021/20 renegade¿catheter was selected and the same issue occurred.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
RENEGADE?
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4130147
MDR Text Key19486072
Report Number2134265-2014-06004
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Model NumberM001182480
Device Catalogue Number18-248
Device Lot Number0016890324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2014
Initial Date FDA Received09/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/10/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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