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

Model Number M00562670

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A medium oval flexible sensation snare was received for analysis.Visual evaluation of the returned device revealed that there were several bends and kinks along the catheter.Additionally, the handle cannula and the 2 in 1 connector were detached and the loop over extended.Functional evaluation revealed that the device did not retract correctly.No other issues with the device were noted.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, it is possible that the bends and kinks along the catheter were caused due to procedure practices such as user technique, handling or anatomical conditions, based on the fact that the problem was noticed inside the patient.Additionally, during the manufacturing process the units were inspected as per procedure, catheter assembly and flaring, in order to avoid bends or kinks in the catheter, confirming the devices did not have kinks or bends during the manufacturing process.The analysis of the device along with the event description, lead to conclude that this failure mode of working length bent/kinked was related to procedure practices.Therefore, the most probable cause for this failure mode is adverse event related to procedure.The loop extension failed due to the handle cannula and the 2 in 1 connector were detached and it caused that the loop over extended.However, the cause of these failure modes could not be established and it will be further investigated why these conditions occurred.Therefore, the most probable cause for these failures found are manufacturing deficiency.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure the snare loop was unable to be retracted back into the catheter.The procedure was completed with another sensation 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 okay.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the 2 in 1 connector were detached.

• 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, coyal; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9818481
• MDR Text Key: 190845282
• Report Number: 3005099803-2020-00853
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: 08714729748083
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941750
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: M00562670
• Device Catalogue Number: 6267S
• Device Lot Number: 0024697822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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