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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE Back to Search Results
Model Number M00561821
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a cold polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the snare grasped the polyp, but could not resect the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a cold polypectomy procedure performed on an unknown date.During the procedure and inside the patient, the snare grasped the polyp, but could not resect the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results- a rotatable small oval med stiff snare was received for analysis.Visual inspection of the returned device revealed no damages were found.Functional testing was performed, and the loop could extend and retract well.The 2-in-1 connector passed dimensional testing.Electrical testing was performed, and the device failed the test since the 2 in 1 connector was provoking the connection.Per the destructive test, the active cord was in good condition; cannulas in the proximal section and 3 rot wires were in good condition.No other problems were noted.The reported complaint of loop failure to cut was not confirmed since the device cannot be functionally evaluated concerning anatomical/procedural factors encountered during the procedure.During the product analysis, it was found that the device failed the electrical test and this problem was related to a component manufactured by an external supplier.This problem was likely due to the manufacturing process.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is manufacturing deficiency since the problem is traced to the manufacturing process a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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Brand Name
ROTATABLE SNARE
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16023843
MDR Text Key308390059
Report Number3005099803-2022-07644
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729283980
UDI-Public08714729283980
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561821
Device Catalogue Number6182
Device Lot Number0030010914
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2022
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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