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

Model Number	M00550340
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the airway via bronchoscope during a frozen lung biopsy procedure performed on (b)(6) 2024.During preparation, the balloon burst when the pressure was applied.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.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.Additional information received on june 23, 2024.It was reported that the balloon burst when the pressure was applied at 8atm.Additionally, it was confirmed that the balloon was leaking liquid when inflated inside the patient.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: the returned cre pulmonary balloon was analyzed, and a visual and microscopic examination found the balloon was torn longitudinally.No damages were found on the catheter of the device.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of the balloon burst was not confirmed.The longitudinal tear found could have been interpreted by the customer as the reported event of a balloon burst.The balloon was found to be torn longitudinally, likely due to factors encountered during the procedure, such as excess pressure, the interaction with other devices, or anatomical affairs.However, it is possible that interaction with any sharp surface during the procedure could have created friction, causing the balloon to be torn longitudinally.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 attempted to be used in the airway via bronchoscope during a frozen lung biopsy procedure performed on (b)(6) 2024.During preparation, the balloon burst when the pressure was applied.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.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.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Additional information: block b5 has been updated based on additional information received june 23, 2024.Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the airway via bronchoscope during a frozen lung biopsy procedure performed on (b)(6) 2024.During preparation, the balloon burst when the pressure was applied.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.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.Additional information received on june 23, 2024.It was reported that the balloon burst when the pressure was applied at 8atm.Additionally, it was confirmed that the balloon was leaking liquid when inflated inside the patient.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19558509
• Report Number: 3005099803-2024-02792
• Device Sequence Number: 4850640
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: 08714729456223
• 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,Followup
• Report Date (Section B): 10/02/2024

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 Model Number: M00550340
• Device Catalogue Number: 5034
• Device Lot Number: 0032838189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/23/2024; 09/10/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/16/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG