Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE Back to Search Results
Model Number M0056182
Device Problems Electrical /Electronic Property Problem (1198); Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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 rotatable snare was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the first polyp was energized and it was able to be removed by the snare but the second polyp was not energized and could not be removed.The procedure was completed with a rotatable snare from a different lot number.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: problem code 1198 captures the reportable event of device delivers energy intermittently.Problem code 2587 captures the reportable event of loop failure to cut.Block h10: the returned rotatable snare was analyzed, and a visual evaluation noted that no damages were found.A functional evaluation noted that the device was able to extend, retract, and rotate without any problem.A continuity test was also performed and the device passed the continuity test since the device's electrical resistance was within specification, indicating a proper connection.No other issues with the device were noted.The reported event of device delivers energy intermittently was not confirmed since the device passed the continuity test upon return.The reported event of loop failure to cut was not 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 is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the information available, the investigation concluded that the most probable cause is no problem detected.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a rotatable snare was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the first polyp was energized and it was able to be removed by the snare but the second polyp was not energized and could not be removed.The procedure was completed with a rotatable snare from a different lot number.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTATABLE SNARE
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11117061
MDR Text Key225289901
Report Number3005099803-2020-06573
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729283980
UDI-Public08714729283980
Combination Product (y/n)N
PMA/PMN Number
K160637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0056182
Device Catalogue Number6182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-