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

Model Number M00552350

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

Block g4: premarket / 510(k) #: k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of needle detached.

Event Description

It was reported to boston scientific corporation that an acquire pulmonary needle was used in the bronchial wall during a lung biopsy procedure performed on (b)(6)2023.During the procedure, the needle tip broke and remained stuck in the bronchial wall during the third puncture.The needle tip was removed using forceps and the patient had mild bleeding.The bleeding was treated by administering a 500mg transamine tablet to the patient to control the bleeding.The procedure was completed using another acquire pulmonary needle.It was reported that a computed tomography (ct) scan of the thorax was suggested to ensure no foreign body remained, however it is unknown at this time if one was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block g4: premarket / 510(k) #: k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of needle detached.Block h10: investigation results one acquire pulmonary needle was received for analysis.Visual analysis of the returned device found that the working length was kinked near the handle and the stylet returned partially loading.The needle was found broken in the distal part.It was identified during a microscope inspection that the distal tip of the needle was bent.A functional inspection was performed by actuating the handle, and the needle came out without difficulty.No other device problems were noted.The reported event of "distal tip detached" is confirmed since the needle was broken at the distal end.It was determined the working length was kinked near the handle and identified that the distal tip of the needle was bent under a microscope.It is most likely the customer may have had to apply excessive force to extend the needle due to anatomical factors or the technique employed, resulting in the observed device problems.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an acquire pulmonary needle was used in the bronchial wall during a lung biopsy procedure performed on (b)(6) 2023.During the procedure, the needle tip broke and remained stuck in the bronchial wall during the third puncture.The needle tip was removed using forceps and the patient had mild bleeding.The bleeding was treated by administering a 500mg transamine tablet to the patient to control the bleeding.The procedure was completed using another acquire pulmonary needle.It was reported that a computed tomography (ct) scan of the thorax was suggested to ensure no foreign body remained, however it is unknown at this time if one was completed.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: 16886818
• MDR Text Key: 314743470
• Report Number: 3005099803-2023-02315
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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: 0027778523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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