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 SENSATION SHORT THROW; 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 SENSATION SHORT THROW; SNARE, FLEXIBLE Back to Search Results
Model Number M00562671
Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 short throw was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the 27mm snare was being used to remove a pedunculate polyp and when the snare was in place the snare wouldn't close and wouldn't conduct energy to cut.This caused the snare to become logged in the polyp and had to be cut at the handle to be removed.The procedure was completed with another sensation short throw and the polyp was removed in piece meal sections.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 fine.
 
Manufacturer Narrative
Block h6: problem code a150208 captures the reportable event of loop entrapment.Block h10: the returned sensation short throw was analyzed, and a visual evaluation noted that the device was returned with the working length and wire cut off.The wire was found exiting the working length and both components (wire and working length) were noted kinked.The reported issues of failure to deliver energy, loop retraction problem, and loop entrapment of device or device component could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device was returned with the sheath and wire cut off making it impossible to perform any test.It was reported that the snare was embedded in the polyp and intervention was required.Upon device analysis it was noted that the working length and wire were cut off which match with the reported complaint that states that the device was cut.Also, the wire and working length were noted kinked.The user may have applied excessive force trying to remove the device from the polyp resulting in the device damaged.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the information available and the analysis of the returned device, this investigation has been assigned the most probable conclusion code of adverse event related to procedure.This is defined as a complaint where an adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that a sensation short throw was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the 27mm snare was being used to remove a pedunculate polyp and when the snare was in place the snare wouldn't close and wouldn't conduct energy to cut.This caused the snare to become logged in the polyp and had to be cut at the handle to be removed.The procedure was completed with another sensation short throw and the polyp was removed in piece meal sections.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 fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11306742
MDR Text Key231118565
Report Number3005099803-2021-00327
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,health
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/29/2023
Device Model NumberM00562671
Device Catalogue Number6267
Device Lot Number0025781886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-