MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584150
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by a boston scientific employee.There was no healthcare facility involved in this event.Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a truetome 49 was checked after being received in a bsc warehouse on (b)(6) 2024.Foreign material was found inside the unopened pouch of the device.It was reported that the sterile seal was not compromised, as all packaging seals were intact.There was no healthcare facility, procedure or patient involved in this event.Note: a photo of the complaint device was provided, and a blue colored foreign material can be seen inside the sterile device packaging.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a truetome 49 was checked after being received in a bsc warehouse on december 10, 2024.Foreign material was found inside the unopened pouch of the device.It was reported that the sterile seal was not compromised, as all packaging seals were intact.There was no healthcare facility, procedure or patient involved in this event.Note: a photo of the complaint device was provided, and a blue colored foreign material can be seen inside the sterile device packaging.
Additional Manufacturer Narrative
Block e1: this event was reported by a boston scientific employee.There was no healthcare facility involved in this event.Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h11: investigation results the returned truetome 49 was analyzed, and a visual examination found no presence of foreign material inside the pouch.A microscopic inspection was performed, and the pouch was opened and inspected under magnification and a particle was found.The particle was measured, and it was out of specification.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of packaging foreign matter was confirmed.According to the product analysis of the returned device, it was found that the device had evidence of foreign material inside the pouch, the particle was measured and was found out of specification.Based on all gathered information, the most probable root cause is quality control deficiency.An investigation is in place to address this problem.

• Brand Name: TRUETOME 49
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 21045383
• Report Number: 3005099803-2024-06574
• Device Sequence Number: 8409163
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: 08714729827610
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 09/09/2026
• Device Model Number: M00584150
• Device Catalogue Number: M00584150
• Device Lot Number: 0034814486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Sex: Unknown