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

Model Number	M00518251
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Device code relates to problem code for the reported event of needle blocked/occluded.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of six devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-01696 for the first interject¿ sclerotherapy needle, 3005099803-2018-01697 for the second interject¿ sclerotherapy needle, 3005099803-2018-01698 for the third interject¿ sclerotherapy needle, 3005099803-2018-01699 for the fourth interject¿ sclerotherapy needle, 3005099803-2018-01700 for the fifth interject¿ sclerotherapy needle and 3005099803-2018-01701 for the sixth interject¿ sclerotherapy needle.It was reported to boston scientific corporation that an interject¿ sclerotherapy needle was used in the colon during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure it was impossible to inject the product into the working channel.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 stable.
Event or Problem Description
Note: this report pertains to one of six devices during the same procedure.Refer to manufacturer report# 005099803-2018-0196 for the first interject sclerotherapy needle, 3005099803-2018-01697 for the second interject sclerotherapy needle, 3005099803-2018-01698 for the third interject sclerotherapy needle, 3005099803-2018-01699 for the fourth interject sclerotherapy needle, 300599803-2018-01700 for the fifth interject sclerotherapy needle and 300509803-2018-01701 for the sixth interject sclerotherapy needle.It was reported to boston scientific corporation that an interject sclerotherapy needle was used in the colon during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure it was impossible to inject the product into the working channel.The procedure was complete with another interject needle.There were no patient complications reported as a result of this even.The patients' condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Investigation results: an interject needle was received for analysis.A visual evaluation of the returned device revealed that there were no visual defects noted.The returned device looked in good conditions without evidence of damages, specifically the needle does not present any issues.A functional evaluation with the working length formed into two 2 diameter loops found the needle would extend and retract without problems or resistance.The handle operation did not present resistance while actuating the device.Water was injected through the returned device by its proximal end using a syringe and the water could exit by the needle (distal end) without problems.The complaint was not confirmed.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore the most probable cause of this complaint is not confirmed-returned since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.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.

• Brand Name: INTERJECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7563153
• Report Number: 3005099803-2018-01696
• Device Sequence Number: 13768577
• Product Code: FCG
• UDI-Device Identifier: 08714729296478
• UDI-Public: 08714729296478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/14/2018

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: 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: 07/03/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1