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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)
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BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID) Back to Search Results
Model Number M00558220
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  Injury  
Manufacturer Narrative
Premarket / 510(k) #: k163248 & k151895.
 
Event Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the #4r, #7 and #4l lymph nodes in the trachea during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, the distal tip of the needle detached inside the patient after puncture.The tip was not removed since they could not find it.The procedure was completed using another expect pulmonary needle.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block g4: premarket / 510(k) #: (b)(6).Block h6: device problem code a0501 captures the reportable event of needle detachment.Block h10: investigation results: the returned expect pulmonary needle was analyzed.The visual evaluation found that the needle broke off and it was observed bent.The broken part of the needle was not returned.In addition, the working length was observed kinked.During microscope inspection, the broken end of the needle had an irregular shape/bent.No other problems were noted.The reported event was confirmed.Product analysis identified that the needle was bent before the break, this bent could have led the break, and this bent could have been caused by some technique applied by the customer during the procedure and/or some interaction within another device could have also contributed on this issue, once the needle was bent some tough movement could have caused the break off.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.
 
Event Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the #4r, #7 and #4l lymph nodes in the trachea during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2022.During the procedure, the distal tip of the needle detached inside the patient after puncture.The tip was not removed since they could not find it.The procedure was completed using another expect pulmonary needle.There were no patient complications reported as a result of this event.
 
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Brand Name
EXPECT 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 Key15954126
MDR Text Key305237929
Report Number3005099803-2022-07193
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier08714729861409
UDI-Public08714729861409
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
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 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/30/2023
Device Model NumberM00558220
Device Catalogue Number5822
Device Lot Number0026274728
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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