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

Model Number	M00550300
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 being prepared for use in the airway in a pulmonary dilatation procedure to be performed on (b)(6) 2024.During preparation, when the package was opened it was discovered the balloon was broken.The procedure was completed with another cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.The reported event may suggest a balloon burst.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared for use in the airway in a pulmonary dilatation procedure to be performed on (b)(6) 2024.During preparation, when the package was opened it was discovered the balloon was broken.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of balloon damaged.Block h12 (correction): block h6 (device code) has been corrected.

• 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: 20926605
• Report Number: 3005099803-2024-06304
• Device Sequence Number: 12039072
• Product Code: KTI
• UDI-Device Identifier: 08714729456186
• UDI-Public: 08714729456186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: M00550300
• Device Catalogue Number: M00550300
• Device Lot Number: 0034763492
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 09/03/2024
• 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 Sex: Unknown