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

Model Number	M00518261
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Although expected, 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 a procedure performed on (b)(6) 2018.According to the complainant, the device has an obstructed lumen.Attempts to gain further information regarding the event have been unsuccessful to date, should any relevant information be provided, a supplemental mdr will be filed.
Additional Manufacturer Narrative
Investigation results: an interject needle was received for analysis.A visual evaluation of the returned device revealed that there were no visual defects noted.The returned device looked in good conditions without evidence of damages, specifically the needle does not present any issues.A functional evaluation with the working length formed into two 2 diameter loops found the needle would extend and retract without problems or resistance.The handle operation did not present resistance while actuating the device.Water was injected through the returned device by its proximal end using a syringe and the water could exit by the needle (distal end) without problems.The complaint was not confirmed.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore the most probable cause of this complaint is not confirmed-returned since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an interject¿ needle was used in a procedure performed on (b)(6) 2018.According to the complainant, the device has an obstructed lumen.Attempts to gain further information regarding the event have been unsuccessful to date, should any relevant information be provided, a supplemental mdr will be filed.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7426916
• Report Number: 3005099803-2018-01118
• Device Sequence Number: 1716396
• Product Code: FCG
• UDI-Device Identifier: 08714729296485
• UDI-Public: 08714729296485
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 10/25/2018
• Device Model Number: M00518261
• Device Catalogue Number: 1826
• Device Lot Number: 18553461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1