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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number M001171030
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the balloon was defective.A 7/2/100 occlusion balloon catheter was advanced to treat the target lesion.However, it was noted that the balloon was not able to fully occlude the blood flow.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was returned for analysis.The catheter shaft was inspected for any defects and 2 kinks were found at 2.5 cm from the distal tip and 7 cm from the distal tip.The balloon was inspected and no defects were noted.The balloon was inflated to the recommended inflation volume and no defects were noted.Both proximal and distal balloon bonds were examined and found to meet the required bond length specification.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
It was reported that the balloon was defective.A 7/2/100 occlusion balloon catheter was advanced to treat the target lesion.However, it was noted that the balloon was not able to fully occlude the blood flow.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.
 
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Brand Name
OCCLUSION BALLOON CATHETER
Type of Device
CATHETER, PERCUTANEOUS
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 Key5220019
MDR Text Key30997026
Report Number2134265-2015-07556
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K062202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2016
Device Model NumberM001171030
Device Catalogue Number17-103
Device Lot Number18168464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2015
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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