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

Model Number	M00550330
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported address: (b)(6).This event was reported by the distributor.The reported physician is dr.(b)(6).The reported healthcare facility is: (b)(6) hospital.Device code (b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the lung during a balloon dilatation procedure performed on (b)(6)2021.During the procedure, the balloon was leaking and couldn't be inflated.The procedure was completed with another cre pulmonary dilation balloon.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 used in the lung during a balloon dilatation procedure performed on (b)(6) 2021.During the procedure, the balloon was leaking and couldn't be inflated.The procedure was completed with another cre pulmonary dilation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reported address: (b)(6).The reported healthcare facility is: (b)(6).Block h6: device code a0504 captures the reportable event of balloon leak.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic analysis was performed, and it was noticed that the balloon had a hole in the proximal side, which confirms the reported event of balloon leaked.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to the water was leaking in the proximal side of the balloon.It is possible that factors encountered during the procedure, such as the interaction with scope.Any other surface or any other object during the procedure could create friction on the balloon, causing the problem of balloon hole during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12488991
• Report Number: 3005099803-2021-04766
• Device Sequence Number: 3350453
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: 08714729456216
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 09/22/2023
• Device Model Number: M00550330
• Device Catalogue Number: 5033
• Device Lot Number: 0026056250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 75