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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY
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BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY Back to Search Results
Model Number M00550300
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the distal trachea during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon ruptured between 13.5 mm to 15mm stage of inflation.It was noted that it might be caused by the guidewire used with the device.Reportedly, saline leaked into the lungs and was suctioned.The patient was moved to recovery and the procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the distal trachea during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon ruptured between 13.5 mm to 15mm stage of inflation.It was noted that it might be caused by the guidewire used with the device.Reportedly, saline leaked into the lungs and was suctioned.The patient was moved to recovery and the procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
 
Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results: a visual examination of the returned complaint device found that the balloon was noted to be burst.No damage found on the catheter of the device.Functional evaluation could not be performed due to the condition of the returned device.This failure is likely due to factors encountered during the procedure, such as the manner the device was handled and/or interaction with the scope, that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
CRE PULMONARY
Type of Device
BRONCHOSCOPE ACCESSORY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9369549
MDR Text Key189734975
Report Number3005099803-2019-05583
Device Sequence Number1
Product Code KTI
UDI-Device Identifier08714729456186
UDI-Public08714729456186
Combination Product (y/n)N
PMA/PMN Number
K023337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/31/2019
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
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model NumberM00550300
Device Catalogue Number5030
Device Lot Number0024037843
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Initial Date Manufacturer Received 10/28/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received12/05/2019
Supplement Dates FDA Received12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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