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

Model Number M00558220

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block g4 premarket / 510(k)#: k163248&k151895.Block h6: imdrf impact code f1001 captures the reportable event of a cancelled procedure.

Event Description

Note: this report pertains to the first of two expect pulmonary needles used during the same procedure.It was reported to boston scientific that an expect pulmonary needle was used during an endobronchial ultrasound (ebus) performed on (b)(6) 2023.During the procedure, the needle failed to lock due to a defective adjustment knob.The needle also punctured the sheath of the echo-bronchoscope device.A second expect pulmonary needle was opened, which had the same problem.As a result, the procedure has been canceled and rescheduled for later the same day.There were no patient complications as a result of this event.

Manufacturer Narrative

Block g4 premarket / 510(k)#: k163248&k151895.Block h6: imdrf impact code f1001 captures the reportable event of a cancelled procedure.Block h10: investigation results the returned expect pulmonary needle was analyzed, and visual inspection showed that the working length was kinked on the proximal side of the device.The device also had marks of being locked.A functional inspection was performed, in which the needle was extended with difficulty and the needle adjust knob failed to lock.No other issues were noted.The reported event was confirmed.Based on the available information, the most probable root cause of the reported event is adverse event related to procedure.It is most likely that procedural factors such as lesion characteristics, handling of the device, and/or the technique used by the physician (force applied) could have resulted in the needle adjust knob failing to lock and the needle difficulty extending.A labeling review was performed and, from the information available, this device was used per instructions for use (ifu)/ product label.

Event Description

Note: this report pertains to the first of two expect pulmonary needles used during the same procedure.It was reported to boston scientific that an expect pulmonary needle was used during an endobronchial ultrasound (ebus) performed on (b)(6) 2023.During the procedure, the needle failed to lock due to a defective adjustment knob.The needle also punctured the sheath of the echo-bronchoscope device.A second expect pulmonary needle was opened, which had the same problem.As a result, the procedure has been canceled and rescheduled for later the same day.There were no patient complications as a result of this event.

• 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: 18292249
• MDR Text Key: 330819919
• Report Number: 3005099803-2023-06464
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: 08714729861409
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 0031436901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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