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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 in the lungs during an endobronchial ultrasound-guided fine needle aspiration performed on (b)(6) 2023.During the procedure, the needle got stuck in the sheath.Pressure was applied and the needle extended with some 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.

Event Description

It was reported to boston scientific corporation that an expect pulmonary needle was used in the lungs during an endobronchial ultrasound-guided fine needle aspiration performed on (b)(6) 2023.During the procedure, the needle got stuck in the sheath.Pressure was applied and the needle extended with some 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.

Manufacturer Narrative

Block g4: premarket / 510(k) #: k163248 & k151895.Imdrf device code a180104 captures the reportable event of foreign material present in device.Investigation results: the expect pulmonary needle was returned, and a visual inspection observed that the working length was kinked at 2 cm of the proximal end of the handle.A microscope inspection noted that the needle was kinked.A functional inspection was performed, and the stylet was able to advance with no issue and no signs of internal occlusion or foreign material were found during flushing.Additionally, a media inspection was performed as the customer provided some pictures which showed some kind of foreign material present on the physician's glove.The reported events were not confirmed.Based on the available information, the most probable root cause of the reported events is no problem detected as there were no signs of foreign material or occlusion, and the stylet was able to advance without issue.However, the working length and needle were found kinked during analysis, therefore the most probable root cause for those issues is adverse event related to procedure, as these could have been caused by the manipulation of the device during its use.

• 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: 18016151
• MDR Text Key: 326652632
• Report Number: 3005099803-2023-05724
• 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,Followup
• Report Date: 12/14/2023

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: 0031416900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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