MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00561600
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: CAPTIVATOR EMR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10142834
• Report Number: 3005099803-2020-02259
• Device Sequence Number: 16784522
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2020
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0024003829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1