MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER INTERJECT¿; BIOPSY NEEDLE KIT

Model Number	M00518251
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
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 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 a gastroscopy procedure performed on (b)(6) 2018.According to the complainant, during preparation, when trying to inject, the liquid did not leave the needle.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
An interject needle was returned for analysis.A visual evaluation of the returned device revealed that there were no visual defects noted, the returned device looks under good conditions without evidence of damages.Functional evaluation with the working length formed into two 2¿ diameter loops found the needle would extend and retract without issue.The handle operation was smooth when actuating the device.A second functional inspection was performed, a spare lab syringe was filled with water, several attempts to inject the water were made but they were unsuccessful, the water did not come out from the needle tip.The device was disassembled and an occlusion was found blocking the inner sheath at the proximal side of the needle.The reported complaint that the needle was noticed to be occluded was confirmed.Based on the information available and the analysis performed the complaint will be documented as "manufacturing execution error", the manufacturing process was not executed as validated/as designed.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the stomach during a gastroscopy procedure performed on (b)(6) 2018.According to the complainant, during preparation, when trying to inject, the liquid did not leave the needle.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7575939
• Report Number: 3005099803-2018-01826
• Device Sequence Number: 217581
• Product Code: FCG
• UDI-Device Identifier: 08714729296478
• UDI-Public: 08714729296478
• Combination Product (Y/N): N
• PMA/510(K) Number: K012864
• 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): 05/23/2018

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: 08/15/2020
• Device Model Number: M00518251
• Device Catalogue Number: 1825
• Device Lot Number: 21014959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/29/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR