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

Model Number	M00518101
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual evaluation of the returned device presented no visible failures.Functional evaluation was performed.Needle was able to extend and retract without any issues.Water was injected through the device and flow without any issue.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 root cause selected for the reported failure is not confirmed.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an interject¿ needle was used in a procedure performed on (b)(6) 2017.According to the complainant, during preparation the local injection solution did not come out.The procedure was completed with another interject¿ needle.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 fine.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6662954
• Report Number: 3005099803-2017-01785
• Device Sequence Number: 18860511
• Product Code: FCG
• UDI-Device Identifier: 08714729296416
• UDI-Public: (01)08714729296416(17)20200125(10)20209380
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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: 01/25/2020
• Device Model Number: M00518101
• Device Catalogue Number: 1810
• Device Lot Number: 20209380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1