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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE Back to Search Results
Model Number M00562672
Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation that a sensation short throw was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was used to attempt to cut through a polyp, but it did not pull through smoothly.Then it was tried with cautery with a bovie unit and there was no current flowing to the device and there were no signs of blanching.The snare was securely attached to the active cord and there was no problem noted with the cautery pin.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was used to attempt to cut through a polyp, but it did not pull through smoothly.Then it was tried with cautery with a bovie unit and there was no current flowing to the device and there were no signs of blanching.The snare was securely attached to the active cord and there was no problem noted with the cautery pin.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a sensation short throw snare was received for analysis.Visual inspection of the returned device revealed no problems.Dimensional inspection of the 2 in 1 was compared with the go no go fixture (active cord gauge) and it was within expectation.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, it could extend and retract well.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 reported complaint of failure to deliver energy since the device passed the electrical test.Device analysis found no problems with the device during visual and functional test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.
 
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Brand Name
SENSATION SHORT THROW
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 Key15916589
MDR Text Key305246072
Report Number3005099803-2022-07014
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729268819
UDI-Public08714729268819
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562672
Device Catalogue Number6267-20
Device Lot Number0029966182
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2022
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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