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	10/26/2017
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 esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure the needle was blocked and could not inject.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 stable.
Additional Manufacturer Narrative
Investigation results.A visual evaluation of the returned device revealed no physical defects.The device returned with residues that were preset in the device indicating use and handling.A functional evaluation was performed and revealed that water was able to be injected by using a sample of syringe.There was no occlusion found.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed 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 the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure the needle was blocked and could not inject.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 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: 7046494
• Report Number: 3005099803-2017-03360
• Device Sequence Number: 1901403
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 10/26/2017

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: 11/01/2019
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0019909297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 67