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

Model Number	M00550350
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the bronchi during a procedure performed on (b)(6) 2022.During the procedure, the balloon broke.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual examination that no damages were found on the balloon and catheter of the device.A functional evaluation was performed by attaching the device to an alliance inflation system.The balloon was inflated without a problem and no damages were found.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.No damages were found on the returned balloon, and it inflated properly during functional testing.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the bronchi during a procedure performed on (b)(6) 2022.During the procedure, the balloon broke.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15540964
• Report Number: 3005099803-2022-05720
• Device Sequence Number: 16633757
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/16/2022

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 Expiration Date: 02/01/2024
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0026731348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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