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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES Back to Search Results
Model Number M00561600
Device Problems Device Difficult to Setup or Prepare (1487); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that two captivator endoscopic mucosal resection devices were used during a mucosectomy procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, the ligator cap did not match nor would fit at the tip of the pentax model eg-2990-i standard gastroscope.The same issue occurred with the second captivator endoscopic mucosal resection device.Reportedly, the patient was already sedated and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results: the returned captivator endoscopic mucosal resection device was analyzed, and a visual evaluation noted that one captivator snare and an emr pathology were returned in its original box.There were no visual defects on the components and were unused.It was observed that the plastic sealed package of the ligator head was opened, and no issues were observed to the ligator head.Dimensional examination was performed on the inner diameter of the flex adapter, and it was confirmed to be within specification.No failures were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that two captivator endoscopic mucosal resection devices were used during a mucosectomy procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, the ligator cap did not match nor would fit at the tip of the pentax model eg-2990-i standard gastroscope.The same issue occurred with the second captivator endoscopic mucosal resection device.Reportedly, the patient was already sedated and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
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Brand Name
CAPTIVATOR EMR
Type of Device
ENDOSCOPE AND/OR ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10142834
MDR Text Key194784264
Report Number3005099803-2020-02259
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729842675
UDI-Public08714729842675
Combination Product (y/n)N
PMA/PMN Number
K140726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/12/2020
Device Model NumberM00561600
Device Catalogue Number50662
Device Lot Number0024003829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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