MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXCELON¿; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00564121
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in an unknown anatomy area on an unknown date.The name of the procedure was not reported.According to the complainant, during preparation, it was noted that the needle was pushed out the side of the catheter.

• Brand Name: EXCELON¿
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7239202
• Report Number: 3005099803-2018-00200
• Device Sequence Number: 16182488
• Product Code: EOQ
• UDI-Device Identifier: 08714729456476
• UDI-Public: 08714729456476
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040018
• 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): 01/15/2018

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: 10/31/2018
• Device Model Number: M00564121
• Device Catalogue Number: 6412
• Device Lot Number: 18493381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1