MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLE; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number UNK896

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The upn and lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.However, the complainant reported that the device was not expired.Reported event of needle tip bent.The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an expect pulmonary transbronchial aspiration needle was used during an endobronchial ultrasound ebus) procedure performed on an unknown date.According to the complainant, during the procedure, the user pushed into the patient's cartilage with force and the exposed needle bent at an angle approximately 1 centimeter from its distal tip.Additionally, the complainant reported that the underside of the expect pulmonary scope adapter leaked when flushing the adapter with lidocaine and saline.The procedure was completed with a different 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.

• Brand Name: EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLE
• Type of Device: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• 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: 5651948
• MDR Text Key: 45096884
• Report Number: 3005099803-2016-01224
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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