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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 M00562402
Device Problems Entrapment of Device (1212); Failure to Cut (2587)
Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)
Event Date 05/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device was not kept and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure the snare did not seem like it cut all the way through the tissue.Reportedly, the tissue had to be pulled away with the snare rather than cut.The complainant suspected that the difficult polypectomy may have resulted in a perforation, however it was not confirmed.It is unknown if there were interventions performed or treatment given to the patient for the perforation as no information was provided.It was not reported whether the perforation has been resolved.Although the procedure was reported to be completed, it was not reported how it was completed.The patient's current condition is unavailable per customer.
 
Manufacturer Narrative
Block h6: problem code 1212 captures the reportable event of loop entrapment.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device was not kept and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.Block h11: blocks b1, b2 and b5 have been updated with the additional information received on (b)(6) 2020.Blocks f10 (patient codes), h1, h6 (patient codes) and h10 have been updated with the additional information received on (b)(6) 2020.Blocks h6 (evaluation conclusion code) and h10 have been updated based on the investigation closure date of (b)(6), 2020.
 
Event Description
It was reported to boston scientifc corporation that a captiflex medium oval flexible snare was used during a colonscopy procedure peformed on(b)(6), 2020.According to the complainant, during the procedure, the nurse manager called and reported a difficult polypectomy and she suspected that there might have been a perforation because the snare did not seem to cut all the way through and they had to pull the tissue away instead of cutting through it.Reportedly, it was unknown if there were interventions performed or treatment given to the patient for the perforation as no information was provided.It was not reported whether the perforation has been resolved.Although the procedure was reported to be completed, it was not reported how it was completed.The patient's current condition, is unavailable per customer.The hospital did not keep the device.*** additional information received on (b)(6), 2020 *** according to the complainant, the patient did not experience perforation.The physician kept the patient several hours after the procedure to make sure there was no complaints.The two polyps removed was at 70 cm.The patient was not put on any medication after procedure.
 
Manufacturer Narrative
Block h6: problem code 1212 captures the reportable event of loop entrapment.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device was not kept and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonscopy procedure peformed on (b)(6) 2020.According to the complainant, during the procedure, the nurse manager called and reported a difficult polypectomy and she suspected that there might have been a perforation because the snare did not seem to cut all the way through and they had to pull the tissue away instead of cutting through it.Reportedly, it was unknown if there were interventions performed or treatment given to the patient for the perforation as no information was provided.It was not reported whether the perforation has been resolved.Although the procedure was reported to be completed, it was not reported how it was completed.The patient's current condition, is unavailable per customer.The hospital did not keep the device.Additional information received on june 10, 2020: according to the complainant, the patient did not experience perforation.The physician kept the patient several hours after the procedure to make sure there was no complaints.The two polyps removed was at 70 cm.The patient was not put on any medication after procedure.
 
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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 Key10121217
MDR Text Key194125663
Report Number3005099803-2020-02102
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501640
UDI-Public08714729501640
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,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/29/2023
Device Model NumberM00562402
Device Catalogue Number6240-40
Device Lot Number0025133479
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/08/2020
Initial Date FDA Received06/04/2020
Supplement Dates Manufacturer Received06/10/2020
09/22/2020
Supplement Dates FDA Received07/01/2020
10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2759-2020
Patient Sequence Number1
Patient Outcome(s) Other;
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