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: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH
  • 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
 

BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO KIT; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 29460
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in the uterine fibroids.A 135/10 renegade hi flo kit was selected for use.The device was placed down a 5f non-boston scientific microcatheter, but it got stuck and would not advanced.Both device were removed together from the patient and it was noted to be ripped/frayed 10-15 cm distal to the hub.A new renegade was replaced but still could not advanced.The procedure was completed using a different microcatheter with another renegade device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The hub and shaft were visually inspected when returned.The renegade device showed multiple bends and kinks located on the shaft.There was a stretched and fractured shaft located 6.2cm from the hub.The renegade devices product specification states the proximal od should be 0.0038+0.0013/0-0.0026.The proximal end of the renegade that was returned was checked using a laser micrometer and measured 0.0386 which is in specification per the document.The distal end of the shaft measurement should be 0.0367+0.0013/-0.0026 and this device measured 0.0360 at the highest area of the shaft.The product must be compatible with (pass through uninhibitedly) 0.038 (0.97 mm) guidewire compatible guiding catheters (0.042 (1.1 mm) inside diameter).The device was attempted to be inserted into a 5fr angiographic catheters that were returned and the device would not transcend through the catheter.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the uterine fibroids.A 135/10 renegade hi flo kit was selected for use.The device was placed down a 5f non-boston scientific microcatheter, but it got stuck and would not advanced.Both device were removed together from the patient and it was noted to be ripped/frayed 10-15 cm distal to the hub.A new renegade was replaced but still could not advanced.The procedure was completed using a different microcatheter with another renegade device.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RENEGADE HI-FLO KIT
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15416630
MDR Text Key299867587
Report Number2124215-2022-34065
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729280774
UDI-Public08714729280774
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2023
Device Model Number29460
Device Catalogue Number29460
Device Lot Number0028400939
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2021
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 SexFemale
-
-