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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK RENEGADE¿ HI-FLO¿; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC - CORK RENEGADE¿ HI-FLO¿; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number M001182890
Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device showed a break approximately 22cm from the hub.The device was hydrated and the outside coating was inspected.There was no forseen issue with the coating.Further visual examination did show that the shaft showed some damage approximately 6.5 to 8 cm from the tip.Due to the damage of the catheter shaft, it could not be inserted into a micro-catheter due to the pushability of the device was compromised.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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
Reportable based on device analysis completed on 03-jan-2017.It was reported that catheter had difficulty inserting and had coating issue.The target lesion was located in the moderately tortuous hepatic artery.A 135mmx20mm renegade¿ hi-flo¿ was selected for use.During preparation, after the device was wet with water, the entire part was noted to be lumpy and the base part was sticky.This caused difficulty in inserting of the device.The procedure was completed with another of the same device.No patient complications reported and patient's condition was stable.However, device analysis revealed that device showed a break approximately 22cm from the hub.
 
Manufacturer Narrative
The most probable root cause corrected from operational context to handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
Reportable based on device analysis completed on 03-jan-2017.It was reported that catheter had difficulty inserting and had coating issue.The target lesion was located in the moderately tortuous hepatic artery.A 135mmx20mm renegade¿ hi-flo¿ was selected for use.During preparation, after the device was wet with water, the entire part was noted to be lumpy and the base part was sticky.This caused difficulty in inserting of the device.The procedure was completed with another of the same device.No patient complications reported and patient's condition was stable.However, device analysis revealed that device showed a break approximately 22cm from the hub.
 
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Brand Name
RENEGADE¿ HI-FLO¿
Type of Device
CATHETER, CONTINUOUS FLUSH
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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6266199
MDR Text Key65371979
Report Number2134265-2017-00061
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K000177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Model NumberM001182890
Device Catalogue Number18-289
Device Lot Number19616126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2016
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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