MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562672

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2020

Event Type  Injury  

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.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed 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 sensation medium oval flexible snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the heat was not working properly as if cautery was not effective.They checked all machine settings and even swapped it out to make sure it was working but it felt like there was less heat energy produced than normal.Reportedly, the active cord was properly attached to the snare and no issues were noted with the handle and cautery pin.The procedure was completed with another sensation snare.The patient was fine at the conclusion of the procedure however, there was bleeding in the colon area and they used clips to resolve the bleeding but the patient was sent for hospitalization to be monitored.The patient's current condition post procedure was reported to be good.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 256 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9857070
• MDR Text Key: 188846117
• Report Number: 3005099803-2020-01235
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729268819
• UDI-Public: 08714729268819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

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 Model Number: M00562672
• Device Catalogue Number: 6267-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization