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

Model Number M00562651

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).(product investigation): the returned sensation large oval med stiff snare was analyzed and a visual evaluation noted that the manufacturing seal of the pouch was incomplete.No specific failure was reported against the device.Therefore, no assessment on the confirmation of the complaint can be made.However, the product analysis revealed that the device had the packaging seal incomplete.It is important to mention that this event was not associated with a patient nor a procedure involved.An investigation was opened to further investigate the most probable cause for this issue but since the investigation is still in progress, the investigation conclusion code selected for this complaint is cause not established.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was returned for evaluation on (b)(6) 2020.According to the complainant, a sensation large oval med stiff snare was unpacked on (b)(6) 2020 in (b)(6) hospital affiliated to (b)(6) university.There were five small packages inside, but the outer packaging on one of the devices was not well sealed.Reportedly, the other 4 small packages were not physically checked if the devices also have incomplete seal.This event was not associated with a patient nor a procedure involved.

• 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: 11109550
• MDR Text Key: 226073790
• Report Number: 3005099803-2020-06514
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: M00562651
• Device Catalogue Number: 6265
• Device Lot Number: 0024890051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• 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