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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 M00562693
Device Problems Retraction Problem (1536); Failure to Cut (2587); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used in the colon of a male patient for screening a polyp during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician attempted to use the snare multiple times.During the second pass, when the physician used the snare, it would not retract into the catheter and it failed cut the target polyp.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be okay.
 
Manufacturer Narrative
Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Problem code 2907 captures the reportable failure based on product investigation results of cautery pin detached.Block h10: investigation results a sensation snare was received for analysis.Visual inspection of the returned device revealed that the handle cannula and the 2 in 1 connector were detached.Functional inspection was not performed due to the device condition.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.An evaluation was executed and concluded that the handle cannula detached issue was caused due to the thread in the 2 in 1 connector and due to this the cannula was partially secured to the active cord insertion during the screwing process.Due to these failures, the loop was unable to retract and cut the polyp.Based on the information available and the analysis performed, the most probable root cause classification is cause traced to component failure.There is an investigation in place to address this issue.A risk review of the sensation - snares was completed using the snare family global design fmea, bsc, bv and confirmed that the event of "snare-loop-failure-to-cut" and "snare-loop-retraction problem " were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used in the colon of a male patient for screening a polyp during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician attempted to use the snare multiple times.During the second pass, when the physician used the snare, it would not retract into the catheter and it failed cut the target polyp.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be okay.
 
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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
MDR Report Key10396449
MDR Text Key202619588
Report Number3005099803-2020-03278
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501671
UDI-Public08714729501671
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/08/2020
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 Date11/10/2022
Device Model NumberM00562693
Device Catalogue Number6269-40
Device Lot Number0024751265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2020
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received09/16/2020
Supplement Dates FDA Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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