MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE

Model Number	M00518361
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	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Imdrf device code a1802 captures the reportable event of packaging foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that an interject sclerotherapy needle was to be used in a procedure on (b)(6), 2023.Prior to the procedure, before opening the package, a foreign material was noted in the sealed packaging.It was not reported what device was used to complete the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an interject sclerotherapy needle was to be used in a procedure on (b)(6) 2023.Prior to the procedure, before opening the package, a foreign material was noted in the sealed packaging.It was not reported what device was used to complete the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information despite good faith efforts.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code (b)(6) captures the reportable event of packaging foreign matter.Block h10: (product investigation) media analysis of the photos provided by the customer determined there was a visible hair inside the device pouch.The interject was then returned to boston scientific and the investigation confirmed the presence of a hair inside the pouch.With all the available information, boston scientific confirmed the reported clinical observations.The cause of the hair inside the sealed pouch was traced to an issue within the manufacturing process.Since this product lot was manufactured, the interject manufacturing site has changed.Boston scientific has reviewed the procedures at the current manufacturing site and confirmed the procedures include an inspection of packaged devices to ensure they are free of foreign material.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE
• 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: 16562878
• Report Number: 3005099803-2023-01257
• Device Sequence Number: 5691021
• Product Code: FCG
• UDI-Device Identifier: 08714729296539
• UDI-Public: 08714729296539
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K012864
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 09/22/2025
• Device Model Number: M00518361
• Device Catalogue Number: 1836
• Device Lot Number: 0030205156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown