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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION PROFILE; SNARE, FLEXIBLE Back to Search Results
Model Number M00562531
Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 profile extra small oval flexible snare was used during a cold polypectomy procedure performed on an unkonwn date.According to the complainant, during the procedure and inside the patient, resistance was met when opening and closing the snare loop, therefore, mucosal resection could not be performed.It was reported to be defective because there was no angle manipulation performed to the endoscope and no tortuous area at the time of treatment.Reportedly, an olympus pcf scope was used.The procedure was completed with another profile snare.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1: the initial reporter address is (b)(6) block h6: problem code 2587 captures the reportable event of snare loop failure to cut.Block h10: (product investigation) one profile snare was received for analysis.The device did not have any defective condition.Functional evaluation of the returned device found that the device was tested in the 10-inch loop fixture and it was able to extend completely and retract without issues.Continuity test was also performed and the device passed the continuity test since the device's electrical resistance was 9.5 ohms, indicating a proper connection (the electrical resistance shall be less than 20 ohms per non-rotatable snares electrical resistance).Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.Based on the information available and the analysis performed, the most probable root cause for this problem is no problem detected due to the device complaint or problem cannot be confirmed.The loop was in a good shape and the device pass the visual and functional tests.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 profile extra small oval flexible snare was used during a cold polypectomy procedure performed on an unkonwn date.According to the complainant, during the procedure and inside the patient, resistance was met when opening and closing the snare loop, therefore, mucosal resection could not be performed.It was reported to be defective because there was no angle manipulation performed to the endoscope and no tortuous area at the time of treatment.Reportedly, an olympus pcf scope was used.The procedure was completed with another profile snare.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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Brand Name
PROFILE
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10606234
MDR Text Key209169772
Report Number3005099803-2020-04294
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729156628
UDI-Public08714729156628
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/04/2023
Device Model NumberM00562531
Device Catalogue Number6253
Device Lot Number0025299892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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