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

Model Number M00518251

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: an interject needle was returned for analysis.A visual evaluation of the returned device revealed that there were no visual defects noted, the returned device looks under good conditions without evidence of damages.No other anomalies were noted.Functional evaluation with the working length formed into two 2¿ diameter loops found the needle would extend and retract without issue.The handle operation was smooth when actuating the device.A second functional inspection was performed, a spare lab syringe was filled with water, several attempts to inject the water were made but they were unsuccessful, the water did not come out from the needle tip.The device was disassembled and an occlusion was found blocking the inner sheath at the proximal side of the needle.Based on the information available and the analysis performed the complaint will be documented as "manufacturing execution error", the manufacturing process was not executed as validated/as designed.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

An interject needle was received for analysis.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.This has been made a reportable event due to investigation results of needle -blocked/occluded.

• Brand Name: INTERJECT¿
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7640144
• MDR Text Key: 112435150
• Report Number: 3005099803-2018-02103
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 08714729296478
• UDI-Public: 08714729296478
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K012864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: M00518251
• Device Catalogue Number: 1825
• Device Lot Number: 21645556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1