MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	M00518301
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was to be used in the colon for an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During preparation, when removing the device from the packaging box, it was observed that the sterile seal was compromised.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a4: the exact weight of the patient provided is 67.5 kg.Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Additional Manufacturer Narrative
Block a4: the exact weight of the patient provided is 67.5 kg.Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: investigation results the returned interject needle was analyzed, and the device returned without its packaging.The device had no visible damages.The reported event was not confirmed.The device returned without the packaging.The packaging could have been damaged during transport to the health care facility or when it was stored to be used.Due to lack of evidence and without proper evaluation of the device, the most probable root cause of the reported event could not be established.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was to be used in the colon for an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During preparation, when removing the device from the packaging box, it was observed that the sterile seal was compromised.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.

• Brand Name: INTERJECT
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19178514
• Report Number: 3005099803-2024-01800
• Device Sequence Number: 20619899
• Product Code: FBK
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171454
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 12/14/2025
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0030718370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 67 KG