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

Model Number	M00552351
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket / 510(k) #: k163248, k151895.(b)(4).Investigation results: the returned acquire pulmonary needle was analyzed, a visual evaluation noted that the sheath was bent at the proximal and distal sections.The device was placed under magnification and blood residues were observed in the needle.The needle was cut in order to inspect what was blocking the needle to pass the stylet, and it was observed that a possible foreign material was present.A functional evaluation noted that the stylet was removed and loaded but it was unable to exit the needle.No other problems with the device were noted.The product analysis revealed that the needle was obstructed by a foreign material.Materials, testing, analysis and characterization (mtac) was performed on the foreign material and the results showed that the foreign material appeared to be plasticized polyvinyl chloride (pvc) polymer.This component is not part of the composition of the acquire pulmonary needle.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is cause not established.On the other hand, the sheath was bent at the proximal and distal sections.It is possible that the manipulation of the device or the technique used during advancing the device inside the endoscope could have caused the catheter damage.Therefore, the most probable cause of this is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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) 2020.During the procedure, while outside of the patient, the stylet was not able to advance through the shaft of the needle.The device was suctioned out multiple times, however the stylet was not able to be advanced within in the needle.The procedure was completed with another acquire pulmonary needle.There were no patient complications reported as a result of this event.Investigation results revealed that there was a foreign material blocking the inside of the needle; therefore, this is now an mdr reportable event.

• Brand Name: ACQUIRE PULMONARY
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11673224
• Report Number: 3005099803-2021-01542
• Device Sequence Number: 11544429
• Product Code: EOQ
• UDI-Device Identifier: 08714729986232
• UDI-Public: 08714729986232
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 02/18/2023
• Device Model Number: M00552351
• Device Catalogue Number: 5235
• Device Lot Number: 0025233561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1