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

Model Number M00564111

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual evaluation of the device revealed that the sheath and needle were bent approximately 11cm from the distal end.In addition the inner and outer sheath were detached.Functional analysis could not be performed due to the condition of the device.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 similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in the main carina during a transbronchial needle aspiration (tbna) procedure performed on (b)(6) 2017.According to the complainant, during the procedure the needle was stuck on distal stop.The procedure was completed with this 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 fine.The investigation found that the needle was bent, this is now deemed an mdr reportable event.

• Brand Name: EXCELON¿
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6868393
• MDR Text Key: 86304476
• Report Number: 3005099803-2017-02744
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729456469
• UDI-Public: (01)08714729456469(17)20190131(10)18860143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2019
• Device Model Number: M00564111
• Device Catalogue Number: 6411
• Device Lot Number: 18860143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR