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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE Back to Search Results
Model Number M00562401
Device Problems Retraction Problem (1536); Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare loop failed to retract and did not cut the target polyp.A completely different snare was used to complete the procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: 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 h6: problem code 2587 captures the reportable event of snare loop failure to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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 mdr will be filed.Block h11: blocks h2, h6 and h10 have been updated based on the investigation closure for device not returned.Correction: sections h7 and h9.
 
Event Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare loop failed to retract and did not cut the target polyp.A completely different snare was used to complete the procedure.There were no patient complications reported as a result of this event.
 
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Brand Name
CAPTIFLEX
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10295221
MDR Text Key199698673
Report Number3005099803-2020-02789
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019411
UDI-Public08714729019411
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2023
Device Model NumberM00562401
Device Catalogue Number6240
Device Lot Number0025338467
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2020
Initial Date FDA Received07/20/2020
Supplement Dates Manufacturer Received09/22/2020
Supplement Dates FDA Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2759-2020
Patient Sequence Number1
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