MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number	M00562451
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name ((b)(6)).Initial reporter address 2 ((b)(6)).Block h6: imdrf device code a020503 captures the reportable event of packaging incomplete seal.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for removal of colorectal polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, when taking out the product from the packaging, it was noticed that the plastic-sealed bag packaging had already been opened.The procedure was completed with another of the same device.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 stable.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a020503 captures the reportable event of packaging incomplete seal.Block h11: the returned captivator snare device was analyzed, and a visual inspection was performed, and it was noted that there was no visible damage.The original pouch was open from below.The upper seals were not opened.Additionally, it was possible to confirm that the pouch had manufacturing sealing marks around it.No other problems with the device were noted.The reported event of packaging incomplete seal was not confirmed.Investigation found that the plastic-sealed bag packaging had already been opened.It is not possible to know if the pouch got this open during storage, transport, the manufacturing process, or during the preparation.Therefore, it is not clear what could affect the pouch.Manufacturing records were reviewed, and no deviations within the manufacturing processes were found.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for removal of colorectal polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, when taking out the product from the packaging, it was noticed that the plastic-sealed bag packaging had already been opened.The procedure was completed with another of the same device.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 stable.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22047756
• Report Number: 3005099803-2025-02243
• Device Sequence Number: 15680557
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)250515(10)29411034
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 05/15/2025
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0029411034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG