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

Model Number	M00564101
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual evaluation revealed that the needle was stuck on the proximal side of the hub when received and the needle has perforated the sheath.The sheath was also detached from the handle.Functional analysis was not performed due to the condition of the device.Based on the condition of the returned device the most probable root cause classification for the reported failure is handling damage.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an excelon transbronchial aspiration needle was used in the trachea during a bronchi tissue acquisition procedure performed on (b)(6) 2017.According to the complainant, during preparation the needle failed to extend and was stuck at distal stop.The procedure was completed with another of the same device.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 the investigation found the needle had punctured through the sheath, this is now deemed an mdr reportable event.

• 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: 6990870
• Report Number: 3005099803-2017-03199
• Device Sequence Number: 16450896
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: 08714729456452
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K040018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 20479361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1