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

Model Number	M00564101
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 excelon transbronchial aspiration needle was used in the lungs during a transbronchial needle aspiration (tbna) procedure.According to the complainant, during the procedure, when the device advanced through the scope, it was noted that the needle punctured through the sheath and was bent.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
Visual evaluation revealed that the distal end of the needle was protruding through the sheath and was bent in the section where the sheath was punctured.Functional analysis revealed that the needle would extend and retract when it was placed back in position.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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 lungs during a transbronchial needle aspiration (tbna) procedure.According to the complainant, during the procedure, when the device advanced through the scope, it was noted that the needle punctured through the sheath and was bent.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: EXCELON¿
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6900525
• Report Number: 3005099803-2017-02840
• Device Sequence Number: 566556
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: 08714729456452
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/08/2017

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: 07/10/2020
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 20869873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1