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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

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BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL Back to Search Results
Model Number M0062201090
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an occluder ballon catheter was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.
 
Event Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in a procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the balloon burst.
 
Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results: a visual examination of the returned complaint device confirmed that the balloon burst.It was noticed that the proximal and distal bonds are continuous.Functional analysis could not be performed due to the returned condition of the balloon.There were no other issues noted with the device.This failure is likely due to factors and conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, th most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
OCCLUDER
Type of Device
CATHETER, UROLOGICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8483233
MDR Text Key140921266
Report Number3005099803-2019-01610
Device Sequence Number1
Product Code EYB
UDI-Device Identifier08714729192008
UDI-Public08714729192008
Combination Product (y/n)N
PMA/PMN Number
K133750
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/04/2019
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 Date05/06/2020
Device Model NumberM0062201090
Device Catalogue Number220-109
Device Lot Number0023035830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Initial Date Manufacturer Received 03/12/2019
Initial Date FDA Received04/04/2019
Supplement Dates Manufacturer Received05/20/2019
Supplement Dates FDA Received06/04/2019
Patient Sequence Number1
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