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

Model Number M00518251

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that an interject¿ needle was used during a hemostasis or an injection before emr procedure.According to the complainant, during the procedure it is impossible to inject any fluid inside the needle.The procedure was completed with another interject¿ 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.

Manufacturer Narrative

Investigation results: an interject needle was returned for analysis.A visual evaluation of the returned device revealed that the metal needle was present, properly bonded, and without issue.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.The reported complaint that the needle was noticed to be occluded was confirmed.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

It was reported to boston scientific corporation that an interject¿ needle was used during a hemostasis or an injection before emr procedure.According to the complainant, during the procedure it is impossible to inject any fluid inside the needle.The procedure was completed with another interject¿ 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¿
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7515145
• MDR Text Key: 108286679
• Report Number: 3005099803-2018-01461
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 08714729296478
• UDI-Public: 08714729296478
• Combination Product (y/n): N
• PMA/PMN Number: K012864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: M00518251
• Device Catalogue Number: 1825
• Device Lot Number: 21014959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1