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

Model Number	M00550330
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g4: the remaining premarket/510(k) number is k170759; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the airway.
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 during a balloon dilatation procedure performed on (b)(6) 2025.During the procedure, there was a leakage of liquid.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.
Additional Manufacturer Narrative
Block b5 and block e1 initial reporter address have been updated based on additional information received june 12, 2025.Block e1: the initial reporter address 1 is (b)(6); reported here as the address exceeded the character limit for the designated field.Block g4: the remaining premarket/510(k) number is k170759; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the airway.
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 during a balloon dilatation procedure performed on (b)(6) 2025.During the procedure, there was a leakage of liquid.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.Additional information received on june 12, 2025: it was reported that the balloon was pre-inflated prior to use in the patient.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.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22185364
• Report Number: 3005099803-2025-02717
• Device Sequence Number: 8799344
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: (01)08714729456216(17)271210(10)35458514
• 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): 07/01/2025

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: M00550330
• Device Catalogue Number: M00550330
• Device Lot Number: 0035458514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 12/10/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG