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

Model Number M00562651

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The initial reporter's address is (b)(6).(b)(4).The device has not been received for analysis; 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

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05757 and 3005099803-2020-05759 for the associated device information.It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used to treat a colorectal polyp in the colorectum during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during unpacking and outside the patient, the physician unpacked the device and the sterile bag was found broken and unusable.Reportedly, there were no other issues noted with the device.The procedure was then completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: the initial reporter's address is (b)(6).Block h6: problem code 1444 captures the reportable event of incomplete sterile packaging seal.Block h10: (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.The reported event was confirmed.Device analysis identified that the manufacturing seal of the pouch was incomplete.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

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05755, 3005099803-2020-05757 and 3005099803-2020-05759 for the associated device information.It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used to treat a colorectal polyp in the colorectum during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during unpacking and outside the patient, the physician unpacked the device and the sterile bag was found broken and unusable.Reportedly, there were no other issues noted with the device.The procedure was then completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10920500
• MDR Text Key: 218949801
• Report Number: 3005099803-2020-05755
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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: 12/03/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1