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	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the duodenum during a polypectomy procedure performed on (b)(6) 2021.During preparation, when the physician unpacked the needle, the tip of the needle was detached.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the duodenum during a polypectomy procedure performed on (b)(6) 2021.During preparation, when the physician unpacked the needle, the tip of the needle was detached.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of needle detached.Block h10: investigation results: the returned optiflo hemostasis catheter was analyzed, a visual evaluation was performed and no damages or additional defects were found.The outer sheath was cut to expose the needle and it was not broken, it was properly attached to the device.Therefore, the reported failure of needle detached was not confirmed.Additionally, the inner sheath was narrowed and seemed to be melted.A functional evaluation noted that the needle could not be extended since the outer sheath was cut to expose the needle.Based on all available information and the condition of the returned device, it was concluded that the "narrowed" section of the inner sheath was observed but is unlikely to be the cause of the needle failing to actuate.A "thicker" section was observed, it is likely to be the cause of the needle failing to actuate.The manufacturing process was reviewed and could not identify a likely cause of the "thicker" section because the needle bonding molds would not allow it, the product builders would not be able to process it, and every device is 100% verified to have an actuating needle.Therefore, the investigation conclusion code for the observed issues (inner sheath narrowed/thicker and needle failed to extend) is "no problem detected" since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Since the needle was not broken and it was properly attached to the device it was determined that the investigation conclusion code of the reported complaint of "needle detachment of device or device component" is also "no problem detected" due to the device complaint or problem not being confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: INTERJECT
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11690681
• Report Number: 3005099803-2021-01675
• Device Sequence Number: 3511459
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 01/22/2023
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0025091925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 63