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

Model Number	M00518151
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of the needle was blocked/occluded.A visual evaluation of the returned device found the outer sheath had been kinked at the proximal end near the handle.Functional test was performed by injecting water through the needle hub and no evidence of occlusion was found.Additionally, the handle was actuated and the needle but the needle would not extend due to the kink.The reported event of needle blocked/occluded was not confirmed.Based on all gathered information, it is most likely that during preparation the sheath was kinked due to excessive manipulation and the reported occlusion could have been caused by the sheath kinking.Therefore the most probable root cause of this complaint is handling damage.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¿ sclerotherapy needle was used in the ascending colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation the needle was blocked/occluded and they were unable to inject any contrast dye.The procedure was completed with another interject¿ sclerotherapy 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: 6332210
• Report Number: 3005099803-2017-00263
• Device Sequence Number: 817688
• Product Code: FCG
• UDI-Device Identifier: 08714729415077
• UDI-Public: (01)08714729415077(17)20171110(10)17445864
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K012864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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: Nurse
• Device Expiration Date: 11/10/2017
• Device Model Number: M00518151
• Device Catalogue Number: 1815
• Device Lot Number: 17445864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• 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