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

Model Number M00564101

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 Description

It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in a procedure performed on (b)(6) 2016.According to the complainant, the needle bends easily.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in a procedure performed on (b)(6) 2016.According to the complainant, the needle bends easily.Additional information received on august 01, 2017.During the procedure it was noted that the needle easily bends.Additionally, the syringe didn't fit correctly and wouldn't fully screw on creating a poor vacuum.The procedure was completed with another of the same device and there was ¿no damage to the patient¿.

• 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: 6722861
• MDR Text Key: 80430336
• Report Number: 3005099803-2017-02078
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: (01)08714729456452(17)20190228(10)18920495
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 18920495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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