MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550350
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a tracheal dilation procedure performed on (b)(6) 2023.During the procedure, the balloon was noted to be leaking and the dilation pressure could not be reached.The procedure was completed successfully with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak.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 pinhole in the proximal section.Microscopic inspection found a pinhole located approximately at 55 mm from the tip of the balloon.Media inspection of the photo provided by the customer showed no damages.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon leak.The pinhole is likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, or patient anatomy.It is possible that factors encountered during the procedure, such as the interaction with any surface, could create friction on the balloon and cause a balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a tracheal dilation procedure performed on march 28, 2023.During the procedure, the balloon was noted to be leaking and the dilation pressure could not be reached.The procedure was completed successfully with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was stable.

• Brand Name: CRE PULMONARY
• Common Device Name: 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16806848
• Report Number: 3005099803-2023-02076
• Device Sequence Number: 19599082
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2025
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0029044849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 105 KG