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

Model Number	M00518351
Medical Device Problem Code	Bent (1059)
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).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¿ sclerotherapy needle was used during a procedure on (b)(6) 2017.According to the complainant, during the procedure needle was bent.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 stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.  should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Visual evaluation of the device revealed that the sheath was kinked approximately 1.7cm from the distal end and the needle was in the closed/retracted position.Functional analysis revealed that the needle was unable to be extended due to the condition of the device.Based on the condition of the returned device the most probable root cause classification for the reported failure 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 during a procedure on (b)(6) 2017.According to the complainant, during the procedure needle was bent.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 stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6668698
• Report Number: 3005099803-2017-01927
• Device Sequence Number: 877815
• Product Code: FCG
• UDI-Device Identifier: 08714729296522
• UDI-Public: (01)08714729296522(17)20200208(10)20265789
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 02/08/2020
• Device Model Number: M00518351
• Device Catalogue Number: 1835
• Device Lot Number: 20265789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1