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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE Back to Search Results
Model Number M00561821
Device Problems Failure to Deliver Energy (1211); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2019
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.However, the complainant reported that the device was not expired.(b)(6).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 rotatable small oval med stiff snare was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the snare loop was extended, resistance was felt and when energization was performed, the device failed to deliver energy.Reportedly, the snare was securely attached to the active cord.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.
 
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.However, the complainant reported that the device was not expired.Block e1: (b)(6).Block h6: (b)(4).Block h10: investigation results: visual analysis of the returned device revealed that the working length (strain relief) was bent next to the handle section and scratches were observed inside the catheter.Functional test was performed and the device was able to extend the loop, however, resistance was felt when the handle cannula reached the bent section of the catheter.Electrical resistance testing was also performed and resistance measured at 13.1 ohms, within manufacturing specifications.Device difficult to actuate due to working length (strain relief) bent is considered to be a manufacturing related issue, since it affects the functionality of the device.An investigation was opened to address the relationship between working length bent and actuation issues.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.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 rotatable small oval med stiff snare was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the snare loop was extended, resistance was felt and when energization was performed, the device failed to deliver energy.Reportedly, the snare was securely attached to the active cord.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.
 
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Brand Name
ROTATABLE SNARE
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8366120
MDR Text Key137048082
Report Number3005099803-2019-00846
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,foreig
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561821
Device Catalogue Number6182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2019
Date Manufacturer Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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