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

Model Number	M00550330
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
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 attempted to be used in the bronchus during a pulmonary dilatation procedure performed on (b)(6) 2024.During the procedure, the doctor used the cre balloon to dilate the stricture inside the bronchus and started the 8mm size first but after infilled the saline into the balloon using an encore device the balloon inflated to 8mm larger, 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 occurred during the procedure.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h12: additional information: block b5 (event description) and block h11 (additional mfr narrative) have been updated.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the bronchus during a pulmonary dilatation procedure performed on (b)(6) 2024.During the procedure, the doctor used the cre balloon to dilate the stricture inside the bronchus and started the 8mm size first but after infilled the saline into the balloon using an encore device the balloon inflated to 8mm larger, 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 occurred during the procedure.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Additional information was received on 20jan2025.It was reported that the balloon burst at 8mm and no pieces of the balloon detached 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: 21016456
• Report Number: 3005099803-2024-06440
• Device Sequence Number: 12457620
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: 08714729456216
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K170759
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 0032803798
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 11/07/2023
• 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 Sex: Unknown