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

Model Number M00562673

Device Problems Retraction Problem (1536); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a problem 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 medium oval flexible snare was used to remove a polyp in the colon during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, they have experienced difficulties in cutting the target polyps, and resistance and difficulty closing the snare.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.

• 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: 12469383
• MDR Text Key: 271340079
• Report Number: 3005099803-2021-04750
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0027583593
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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