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

Model Number	M00552350
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket / 510(k) #: k163248 and k151895.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, the first exit of the sheath from the tip of the device was slightly difficult but the needle reached the lump to be punctured.The operator re-introduced the device into the endoscope channel, but the sheath did not slide forward.The needle handpiece was blocked and did not allow any movement of either the sheath or the needle.The procedure was not completed successfully as a second needle device was not available.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ACQUIRE PULMONARY
• Common Device Name: 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: 14679622
• Report Number: 3005099803-2022-03082
• Device Sequence Number: 19992398
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Device Lot Number: 0028753073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown