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

Model Number M00562693

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensation short throw was used during a colonoscopy procedure performed on (b)(6) 2020 according to the complainant, during the procedure, the snare handle mechanism broke and the snare failed to close properly during the polypectomy.Reportedly, the snare loop became stuck in the polyp and the tech was forced to cut the snare wire by the handle in order to force pull the loop into the catheter.The snare was successfully removed from the patient using suction.The procedure was completed with a different captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• 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 01752-1242 ; 5086834015
• MDR Report Key: 10875620
• MDR Text Key: 217345633
• Report Number: 3005099803-2020-05533
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501671
• UDI-Public: 08714729501671
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: M00562693
• Device Catalogue Number: 6269-40
• Device Lot Number: 0024909216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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): Required Intervention
• Patient Age: 53 YR