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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 Problems Entrapment of Device (1212); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-00674 for the associated device information.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used to remove a 10mm polyp in the colon during a colorectal polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, they attempted to cold cut the polyp the snare cannot cut well.Therefore, it was switched to energization but the cut was still bad.The snare was securely attached to the active cord.The possibility of over gripping too many mucous membranes was mentioned.A second rotatable snare of the same lot number was used, however, the device encountered the same problems.The procedure was completed with a third rotatable snare with a different lot number.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-00674 for the associated device information.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used to remove a 10mm polyp in the colon during a colorectal polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, they attempted to cold cut the polyp the snare cannot cut well.Therefore, it was switched to energization but the cut was still bad.The snare was securely attached to the active cord.The possibility of over gripping too many mucous membranes was mentioned.A second rotatable snare of the same lot number was used, however, the device encountered the same problems.The procedure was completed with a third rotatable snare with a different lot number.There were no patient complications reported as a result of this event.Additional information received on february 21, 2022.Only one rotatable snare was unable to cut well and the procedure was completed with a second rotatable snare.Additionally, the snare loop was not embedded in the tissue.
 
Manufacturer Narrative
Block h6: 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 and functional inspections of the returned device revealed no problems had been found.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of "loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and functional test.Additionally, the electrical test passed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: blocks b5, h6 (device codes), and h10 have been updated based on the additional information received on february 21, 2022.
 
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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 Key13559411
MDR Text Key286886818
Report Number3005099803-2022-00671
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 Nurse
Type of Report Initial,Followup
Report Date 03/16/2022
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 Model NumberM00561821
Device Catalogue Number6182
Device Lot Number0028188203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2022
Initial Date FDA Received02/18/2022
Supplement Dates Manufacturer Received02/21/2022
Supplement Dates FDA Received03/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2021
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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