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

Model Number	M00550300
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation catheter was used in the bronks during a dilation of bronks procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the balloon burst.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 issue of balloon burst.Block h10: investigation results.A visual and microscopic examination of the returned complaint device found that the balloon bond detached, which does not confirm the reported event of balloon burst.The catheter of the device had no damages.It was also noticed that the internal lumen of the catheter was stretched.This failure is likely due to factors encountered during the procedure, such as the manner on how the device was handled and manipulated may have caused the reported and encountered problem.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation catheter was used in the broks during a dilation of bronks procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the balloon burst.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: 12910107
• Report Number: 3005099803-2021-06284
• Device Sequence Number: 11998334
• Product Code: KTI
• UDI-Device Identifier: 08714729456186
• UDI-Public: 08714729456186
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 07/04/2024
• Device Model Number: M00550300
• Device Catalogue Number: 5030
• Device Lot Number: 0027608702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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