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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 M00550330
Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left principal bronchus during a dilation procedure performed on (b)(6) 2023.During preparation, the balloon was noticed to have a lateral leakage when tested outside the patient's body.A video submitted by the customer showed a pinhole in the balloon.The procedure was completed with another cre pulmonary dilatation balloon.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.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
 
Manufacturer Narrative
Block h6: imdrf code a041001 captures the reportable event of balloon pinhole.
 
Manufacturer Narrative
Block h6: imdrf code a041001 captures the reportable event of balloon pinhole.Block h10: investigation results: the returned cre pulmonary dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.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 balloon (distal section) located approximately 16 mm from the tip.Media inspection was performed, and based on the video provided by the customer it was possible to observe the balloon with a pinhole.Microscopic inspection found a pinhole located approximately at 16 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event off balloon pinhole can be confirmed.The conclusion is acceptable because, after the product analysis, it was found that the balloon had a pinhole located approximately at 16 mm from the tip of the device.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during/previous the procedure could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed and, from the information available, this device was not used in accordance with the instructions for use (ifu)/product label.
 
Event Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left principal bronchus during a dilation procedure performed on (b)(6) 2023.During preparation, the balloon was noticed to have a lateral leakage when tested outside the patient's body.A video submitted by the customer showed a pinhole in the balloon.The procedure was completed with another cre pulmonary dilatation balloon.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.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17490483
MDR Text Key321085809
Report Number3005099803-2023-04204
Device Sequence Number1
Product Code KTI
UDI-Device Identifier08714729456216
UDI-Public08714729456216
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K023337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00550330
Device Catalogue Number5033
Device Lot Number0030250104
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2022
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 Age56 YR
Patient SexMale
Patient Weight75 KG
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