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

Model Number M00562651

Device Problems Unsealed Device Packaging (1444); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the intestinal tract during a polyp removal procedure performed on (b)(6) 2020.According to the complainant, during preparation and outside the patient, when the patient had enteroscopy on (b)(6) 2020 in (b)(6) hospital affiliated to (b)(6) university, the patient needed polyps removal.So the physician unpacked the device.There were five small packages inside, but the outer packaging on one of the devices was not well sealed.Additionally, there was a visible issue noted with the handle of the device according to the physician's description, however, the dealer could not get more details about it.Reportedly, the other four (4) small packages were not physically checked if the devices also have incomplete seal.The procedure was 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 e1: the reported health care facility 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.Therefore, the as reported code "packaging incomplete seal" can be confirmed.However, the other as reported code "device damaged/defective" cannot be confirmed since no failures were found on the handle section as per the event summary.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

It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the intestinal tract during a polyp removal procedure performed on (b)(6), 2020.According to the complainant, during preparation and outside the patient, when the patient had enteroscopy on (b)(6), 2020 in (b)(6) hospital affiliated to fudan university, the patient needed polyps removal.So the physician unpacked the device.There were five small packages inside, but the outer packaging on one of the devices was not well sealed.Additionally, there was a visible issue noted with the handle of the device according to the physician's description, however, the dealer could not get more details about it.Reportedly, the other four (4) small packages were not physically checked if the devices also have incomplete seal.The procedure was 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: 10992498
• MDR Text Key: 220948701
• Report Number: 3005099803-2020-05870
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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: 12/11/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58