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

Model Number	M00518301
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the colon during a polyps procedure performed on (b)(6) 2021.During the procedure, the outer sheath fell off at the distal tip of the needle.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the colon during a polyps procedure performed on (b)(6) 2021.During the procedure, the outer sheath fell off at the distal tip of the needle.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: medical device problem code a0501 captures the reportable event of sheath detached.Block h10: investigation results an interject sclerotherapy needle was received for analysis.Visual analysis of the returned device found the handle was detached.Under the microscope it was noted that the inner section of the blue hub was inspected and no evidence of attachment or scratches marks were found.No other issues were noted.The reported complaint is confirmed.Based on the available information, the results of the analysis show evidence that suggest that the handle was not properly attached.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency.A documental investigation within e-dhr (electronic device history record) relating to batch 0026040330 was performed and no issues were noted with the batch that may have led to the complaint.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE KIT
• 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: 12847413
• Report Number: 3005099803-2021-05846
• Device Sequence Number: 11782394
• Product Code: FCG
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 09/18/2023
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0026040330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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: 65 KG