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

Model Number	M00518301
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an interject clear needle was used in the colon during a colon endoscopic mucosal resection (emr) procedure performed on (b)(6) 2017.According to the complainant, during the procedure the needle was blocked/occluded.The procedure was completed with another of the same 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 good.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6331616
• Report Number: 3005099803-2017-00230
• Device Sequence Number: 19088213
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: (01)08714729296508(17)20191103(10)19920436
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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
• Report Date (Section B): 01/23/2017

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: Physician
• Device Expiration Date: 11/03/2019
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 19920436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR