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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 M00562422
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The patient's weight was reported to be (b)(6).However, the unit of measurement was not reported.The other physician name is dr.(b)(6).(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 captiflex small oval flexible snare was used in the ascending colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, the snare would not cut through the target polyp using cold snaring and even when cautery was applied.The procedure was completed with another captiflex snare.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 a4: the patient's weight was reported to be 218.However, the unit of measurement was not reported.Block e1: the other physician name is dr.Frank.Block h6: problem code 2587 captures the reportable event of snare loop failure to cut.Block h10: (product investigation) one captiflex 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 12.6 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 since the device complaint or problem cannot be confirmed.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 captiflex small oval flexible snare was used in the ascending colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, the snare would not cut through the target polyp using cold snaring and even when cautery was applied.The procedure was completed with another captiflex snare.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.
 
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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 Key10661645
MDR Text Key221558988
Report Number3005099803-2020-04486
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501657
UDI-Public08714729501657
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2023
Device Model NumberM00562422
Device Catalogue Number6242-40
Device Lot Number0025728647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
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