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

Model Number	M00562651
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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) of (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
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11110248
• Report Number: 3005099803-2020-06516
• Device Sequence Number: 3608886
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1