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

Model Number	M00564121
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual evaluation of the returned device revealed that the unit was received with residues which indicates use and handling.It was found out that the outer sheath was detached from the handle.The needle was kinked adjacent to the handle and the distal part of the needle was bent in several locations.It was also noted that the syringe luer was cracked.Functional analysis was performed by attaching a spare lab syringe filled with water and injected; it was noticed that the water leaked from a side of the syringe luer due to the crack found.The reported complaint 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.
Event or Problem Description
Note: this report pertains to the one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-01599 for the other associated device information.It was reported to boston scientific corporation that an excelon tbna needle was used during an aspiration puncture procedure performed on (b)(6) 2017.According to the complainant, during the procedure the syringe luer leaked.The procedure was not completed because another excelon tbna needle was not available.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.  should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a reportable event based on the investigation results; needle bent.

• 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: 6591706
• Report Number: 3005099803-2017-01591
• Device Sequence Number: 19149100
• Product Code: EOQ
• UDI-Device Identifier: 08714729456476
• UDI-Public: (01)08714729456476(17)20170213(10)16742655
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: 02/13/2017
• Device Model Number: M00564121
• Device Catalogue Number: 6412
• Device Lot Number: 16742655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR