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

Model Number	M00550340
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the balloon popped inside the patient while dilating the airway.The balloon was filled with a 50/50 mixture of omnipaque 350 mgl/ml and normal saline.No further event information was provided.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the director of regulatory affairs.The healthcare facility was not reported on the medwatch form and is unknown.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 a0402 captures the reportable event of a balloon burst.

• 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: 21256504
• Report Number: 3005099803-2025-00119
• Device Sequence Number: 15732596
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: 08714729456223
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: M00550340
• Device Catalogue Number: M00550340
• Device Lot Number: 0033118849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 01/01/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic