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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 M00562671
Device Problems Failure to Cut (2587); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove polyps in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during the procedure and outside the patient, the physician unpacked the device and found that the electrode connection could not be connected and electrically cut.Reportedly, no visible issue was noted with the cautery pin of this device.The target polyp was also not successfully removed using cold snaring.No other issues were noted on the device.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 stable.
 
Event Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove polyps in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during the procedure and outside the patient, the physician unpacked the device and found that the electrode connection could not be connected and electrically cut.Reportedly, no visible issue was noted with the cautery pin of this device.The target polyp was also not successfully removed using cold snaring.No other issues were noted on the device.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 stable.
 
Manufacturer Narrative
Block e1: the initial reporter's address is (b)(6).Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Block h10: investigation results a sensation medium oval flexible snare was received for analysis.Visual inspection of the returned device revealed no visual failures were observed.Functional, dimensional and continuity tests passed.No other issues were noted.Based on the event description, the problem was noticed during procedure and outside the patient.However, during the product analysis, no issues were detected in the device.Based on the information available and the analysis performed, the most probable root cause classification 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.
 
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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 Key10337812
MDR Text Key200855642
Report Number3005099803-2020-03013
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729158141
UDI-Public08714729158141
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,foreig
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2021
Device Model NumberM00562671
Device Catalogue Number6267
Device Lot Number0022961488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight67
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