MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE KIT

Model Number	M00518361
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Captures the reported event of the needle itself fell out of the sheath.The device has been received for analysis.Upon 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 colon during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while they were pulling the injector needle out of the scope, the needle itself fell out of the sheath.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.
Additional Manufacturer Narrative
(b)(4).An interject needle was received for analysis.The analysis of the returned product revealed that no visual defects were noted and the returned device looks under good conditions without evidence of damages, defects or anomalies.No broken, teared and/or detached sections were found on any component of the returned product.A functional evaluation revealed that the working length was formed into two 2" diameter loops and it was noted that the handle operation was smooth; the needle would retract and extend without problems or resistance, also, the needle length fully extended measure was 4.0 mm which is within specifications as per its respective drawing.Evaluation of the returned device showed no visual defects and the device looks under good conditions without evidence of damages, therefore, the most probable root cause classification is no problem detected.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 or Problem Description
It was reported to boston scientific corporation that an interject needle was used in the colon during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while they were pulling the injector needle out of the scope, the needle itself fell out of the sheath.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
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7799673
• Report Number: 3005099803-2018-60103
• Device Sequence Number: 16188459
• Product Code: FCG
• UDI-Device Identifier: 08714729296539
• UDI-Public: 08714729296539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: 06/11/2021
• Device Model Number: M00518361
• Device Catalogue Number: 53585
• Device Lot Number: 0022240928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1