MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT PULMONARY OLYMPUS 22GA - BOX 5; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number M00558221

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an expect pulmonary needle was used in the lung during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2018.According to the complainant, at the very beginning of the procedure, the needle was not visible on the echoendoscope.The physician inspected the needle and realized that the needle tip was missing.An x-ray was then performed and it was confirmed that the needle tip was not inside the patient¿s lung.The tip of the needle was not found.The procedure was completed with another expect pulmonary needle.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.

Event Description

It was initially reported to boston scientific corporation that an expect pulmonary needle was used in the lung during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2018.According to the complainant, at the very beginning of the procedure, the needle was not visible on the echoendoscope.The physician inspected the needle and realized that the needle tip was missing.An x-ray was then performed and it was confirmed that the needle tip was not inside the patient¿s lung.The tip of the needle was not found.The procedure was completed with another expect pulmonary needle.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.Correct information received on august 16, 2018.The event occurred on (b)(6) 2018, not (b)(6) 2018 as initially reported.

Manufacturer Narrative

One expect pulmonary olympus 22ga was returned for analysis.A visual evaluation found working length (needle and sheath) kinked at distal end of the handle with sheath length adjust set at 0.It was noted that the distal section on the needle was broken.The broken section was not returned for analysis.It was also noted that the distal section of the needle was bent near the break and the stylet was also bent at the same location.There were no other issues with the device noted.The reported event was confirmed.The investigation concluded that the observed failures were likely anatomical/procedural factors encountered during the procedure, which limited to the performance of the device.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Blocks have been updated with corrected information, that was received on august 16, 2018.

• Brand Name: EXPECT PULMONARY OLYMPUS 22GA - BOX 5
• Type of Device: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7630463
• MDR Text Key: 112305997
• Report Number: 3005099803-2018-02024
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861430
• UDI-Public: 08714729861430
• Combination Product (y/n): N
• PMA/PMN Number: K151315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: M00558221
• Device Catalogue Number: 5822-5
• Device Lot Number: 21761221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1