• 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 OCCLUDER; CATHETER, UROLOGICAL

  • 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 OCCLUDER; CATHETER, UROLOGICAL Back to Search Results
Model Number M0062201090
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
This report pertains to one of two occlusion balloon catheters used in the same patient and procedure.It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occurred with the second occlusion balloon catheter.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 1074 captures the reportable issue of balloon burst.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
Note: this report pertains to one of two occlusion balloon catheters used in the same patient and procedure.It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occurred with the second occlusion balloon catheter.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.**correction** it was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OCCLUDER
Type of Device
CATHETER, UROLOGICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8586323
MDR Text Key144272278
Report Number3005099803-2019-02391
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,foreig
Type of Report Initial,Followup
Report Date 08/13/2019
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 Date06/12/2020
Device Model NumberM0062201090
Device Catalogue Number220-109
Device Lot Number0023173580
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received05/07/2019
Supplement Dates Manufacturer Received07/23/2019
Supplement Dates FDA Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-