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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 M00550350
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone: (b)(6).(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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the main trachea during a dilation of main airway procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon had a hole.The procedure was completed with another cre pulmonary dilatation balloon device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of 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 main trachea during a dilation of main airway procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon had a hole.The procedure was completed with another cre pulmonary dilatation balloon device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block e1: initial reporter phone: (b)(6).Block h6: problem code 1504 for the reportable issue of balloon hole.Block h10: investigation results: visual examination of the returned complaint device found the balloon did not show visual defects and was in good condition.No damage found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section of the balloon.This failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician, the amount of strength applied by the customer during the movement of the balloon and/or the interaction between the scope, that could have affected device 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 Key9986714
MDR Text Key191670643
Report Number3005099803-2020-01641
Device Sequence Number1
Product Code KTI
UDI-Device Identifier08714729456230
UDI-Public08714729456230
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,foreig
Type of Report Initial,Followup
Report Date 05/27/2020
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 Date06/06/2022
Device Model NumberM00550350
Device Catalogue Number5035
Device Lot Number0023918038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Initial Date Manufacturer Received 03/27/2020
Initial Date FDA Received04/22/2020
Supplement Dates Manufacturer Received04/30/2020
Supplement Dates FDA Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
Patient Weight50
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