MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY OLYMPUS 22GA - BOX 5; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number M00558221

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: exact event date unknown, event occurred in (b)(6) 2023.Block g4: premarket / 510(k) #: k163248 & k151895 block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.

Event Description

It was reported to boston scientific corporation that an expect pulmonary needle was used during a procedure performed in (b)(6) 2023.During the procedure, the needle got stuck in the sheath.Pressure was applied and the needle extended with some foreign steel components.Also, the stylet was hard to reinsert into the needle due to some foreign components in the lumen of the needle.The procedure was completed using a non-boston scientific device.There were no patient complications reported as a result of this event.

• Brand Name: EXPECT PULMONARY OLYMPUS 22GA - BOX 5
• 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: 18014738
• MDR Text Key: 327310939
• Report Number: 3005099803-2023-05779
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861430
• UDI-Public: 08714729861430
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 10/26/2023

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: M00558221
• Device Catalogue Number: 5822-5
• Device Lot Number: 0031518015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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