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

Model Number	M00550011
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect needle was used in the pancreas during an endoscopic ultrasound with fine needle aspiration (eus fna) on (b)(6) 2017.According to the complainant, during the procedure, the needle had punctured through the sheath.Another of the same device was used to complete the case.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
A visual evaluation of the retuned device found that the working length of the needle and sheath were kinked at the distal end of the handle.Further evaluation found the distal tip of the needle was damaged and the distal end of the sheath was punctured by the damaged needle.Function test was performed and the needle was difficult to advance due to punctured sheath.The reported event of punctured sheath was confirmed.Due to anatomical/procedural factors encountered during the procedure, performance of the device was limited. therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an expect needle was used in the pancreas during an endoscopic ultrasound with fine needle aspiration (eus fna) on (b)(6) 2017.According to the complainant, during the procedure, the needle had punctured through the sheath.Another of the same device was used to complete the case.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: EXPECT¿
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6385090
• Report Number: 3005099803-2017-00591
• Device Sequence Number: 19076512
• Product Code: FCG
• UDI-Device Identifier: 08714729790013
• UDI-Public: (01)08714729790013(17)20200118(10)20178711
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100712
• 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): 02/15/2017

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: Physician
• Device Expiration Date: 01/18/2020
• Device Model Number: M00550011
• Device Lot Number: 20178711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1