MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT¿; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00550000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medwatch number is mw5074900.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 or Problem Description
It was reported to boston scientific corporation that an expect ¿ needle was used in the gastric wall, during an endoscopic ultrasonography (eus) procedure with fiducials placement, performed on (b)(6) 2018.According to the complainant, during procedure the needle broke inside the patient¿s gastric wall.It was removed uneventfully with a snare.The procedure was completed with another expect¿ needle.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: EXPECT¿
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7335492
• Report Number: 3005099803-2018-00703
• Device Sequence Number: 10844418
• Product Code: ODG
• UDI-Device Identifier: 08714729790051
• UDI-Public: 08714729790051
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110030
• 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
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2019
• Device Model Number: M00550000
• Device Catalogue Number: 5000
• Device Lot Number: 19588791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention