MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number M00558220

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an expect pulmonary needle was used during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, a little fragment (4mm) from the needle has detached.It is identical to the stylet or 'guidance' of the needle.The detached tip was retrieved using forceps.The procedure was completed with another expect pulmonary needle.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Premarket / 510(k) #: k163248 & k151895.

• Brand Name: EXPECT PULMONARY
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16108029
• MDR Text Key: 306779175
• Report Number: 3005099803-2022-07608
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: 08714729861409
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2023

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 Model Number: M00558220
• Device Catalogue Number: 5822
• Device Lot Number: 0030375677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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