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

Model Number M00552350

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

Premarket / 510(k) #: k163248, k151895.Imdrf device code a0501 captures the reportable event of distal tip detached.

Event Description

It was reported to boston scientific corporation that an acquire pulmonary needle was used in the mediastinal lymph nodes during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2023.During the procedure, about 1 cm of the needle distal tip detached.The procedure was immediately stopped and a search for the tip of the needle in the patient airway, endotracheal tube, and the external area around the patient was unsuccessful.The patient was moved to a fluoroscopy bed, and they searched the patient's lungs radiologically using fluoroscopy and 3d fluoroscopy but could not locate the missing needle tip.During cleaning, the tech brushed the missing needle tip out of the proximal end of the scope.The procedure was completed using a non-bsc device.There were no patient complications reported as a result of this event.

• Brand Name: ACQUIRE 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: 16795821
• MDR Text Key: 313828465
• Report Number: 3005099803-2023-02056
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Device Lot Number: 0030922028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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
• Patient Outcome(s): Required Intervention