MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number	M00558250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).510k number: k163248 & k151895.Although expected, the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used in the same procedure.This manufacturer report pertains to the first expect pulmonary device and manufacturer report # 3005099803-2018-61844 pertains to the second expect pulmonary device.It was reported to boston scientific corporation that two expect pulmonary transbronchial aspiration needles were used with a scope during an endobronchial ultrasound (ebus) procedure on (b)(6) 2018.According to the complainant, after use of the needles in the patient, there was a small black piece of foreign material left inside the patient.The foreign material was removed using forceps.The scope and both needles were inspected and neither appeared damaged, and it was unclear which device the foreign material came from.The procedure was completed with the original two expect pulmonary needles.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
Note: this report pertains to one of two devices used in the same procedure.Manufacturer report # pertains to the first expect pulmonary device and manufacturer report # 3005099803-2018-61844 pertains to the second expect pulmonary device.It was reported to boston scientific corporation that two expect pulmonary transbronchial aspiration needles were used with a scope during an endobronchial ultrasound (ebus) procedure on (b)(6) 2018.According to the complainant, after use of the needles in the patient, there was a small black piece of foreign material left inside the patient.The foreign material was removed using forceps.The scope and both needles were inspected and neither appeared damaged, and it was unclear which device the foreign material came from.The procedure was completed with the original two expect pulmonary needles.The patient's condition at the conclusion of the procedure was reported to be fine.Additional information received january 09, 2018.Reportedly, the complainant believes the foreign material may have been from the scope.
Additional Manufacturer Narrative
Block f10: device problem code 2944 captures the reportable event of foreign matter.Block g5: 510k numbers: k163248 & k151895.Block h10: an expect pulmonary needle device was received for analysis.The foreign material was not returned.A visual evaluation of the returned device revealed the working length (needle and sheath) was kinked at the distal end of the handle and the distal section of the needle was also bent.The needle was fully extended and examined under magnification and was found to be intact, with no damage to the needle tip and sheath tip observed.The length of the needle and sheath were measured and both were within specifications.A functional evaluation was performed and when the handle was actuated, the needle could be extended and retracted.Based on the evaluation of the returned device, the working length kink may have been due to either handling and manipulation of the device by the user or interaction with the scope during the procedure.The foreign material was not returned for analysis and since the device did not show any evidence of broken parts, a clear conclusion about the cause of the reported event could not be determined.Therefore, the most probable cause of the reported event is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: EXPECT PULMONARY
• Common Device Name: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8143873
• Report Number: 3005099803-2018-61843
• Device Sequence Number: 204101
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: 08714729861416
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 0022792308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention