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 Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the stomach during an gastric fundus varicose veins procedure performed on (b)(6) 2020.According to the complainant, during preparation, the physician unpacked the device and found that the needle fell off.The procedure was completed with another interject needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b2: outcomes attrib to adv event: not applicable (correction).Block h6: device problem code 2907 captures the reportable event of the tip of the needle detached.Block h10: the returned interject needle was analyzed, and a visual evaluation noted that the needle was present on the device and it was extended when received.Additionally, the working length was kinked at approximately 49cm from the handle.The distal section of the inner sheath was damaged, including the needle and it was bent.Damaged sections were checked under magnification, it was observed that marks in the material (inner sheath and needle) indicated that there was an interaction with an unknown tool.A functional evaluation was performed and noted that the needle did not retract due to the distal section being severely damaged.Based on all available information and the condition of the returned device, the device showed excessive manipulation and marks of interaction with an unknown tool, suggesting the damages were caused due to manipulation of the device.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, there are controls in place to avoid that a device leaves the manufacturing plant with a defect as the one observed on the device.The investigation concluded the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the stomach during an gastric fundus varicose veins procedure performed on (b)(6) 2020.According to the complainant, during preparation, the physician unpacked the device and found that the needle fell off.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: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10813310
• Report Number: 3005099803-2020-04871
• Device Sequence Number: 4178058
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 11/10/2022
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0024751035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 50