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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II SNARE, FLEXIBLE Back to Search Results
Model Number M00561221
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Electric Shock (2554)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. This event was reported by the clinical engineering manager. The reported healthcare facility is: (b)(6). (b)(6) adverse incident report reference no (b)(4); submitted to (b)(6) by the clinical engineering manager. (b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 captivator ii snare was used during a polypectomy procedure performed on (b)(6) 2021. It was reported that during the procedure, whilst removing a polyp, the patient seemed to get an electric shock with localized pain at the site of the polyp. They had used the snare previously with polyps and there was no issue. They checked all connections from the erbe, ensuring the pad was correctly applied. The site of polypectomy was observed to ensure no perforation had occurred. All connections on the diathermy machine were good and the indicators were green meaning a good circuit was present. The procedure was completed with a non bsc device. The pain was reported to have settled after 30 seconds and the patient was noted to be fine following the procedure. The patient was discharged at 17:10. At 17:45 the patient rang the department stating she had abdominal pain. The physician then suggested that the patient go to a&e. It was reported that it had been noticed that the patient had not attended. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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Brand NameCAPTIVATOR II
Type of DeviceSNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12467783
MDR Text Key271429598
Report Number3005099803-2021-04734
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM00561221
Device Catalogue Number6122
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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