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

Model Number M00560321

Device Problems Entrapment of Device (1212); Failure to Cut (2587); Difficult to Advance (2920); Human-Device Interface Problem (2949)

Patient Problems Hematoma (1884); Perforation (2001)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a sensation small oval med stiff snare was used in an unknown procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device became embedded in the patient's tissue, perforating the patient's mucosa and causing a hematoma.Reportedly, the physician stated that the snares in general do not make a clean cut and rip the tissue.The physician also noted that the sheath that covers the snare is flimsy and does not feed down the channel well.The procedure was completed with this device.

• 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.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8296831
• MDR Text Key: 134729548
• Report Number: 3005099803-2019-00140
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• 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): Other