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

Model Number	M00550320
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 airway during a diagnostic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon ruptured around 2 atm.The procedure was completed with another cre pulmonary 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 airway during a diagnostic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon ruptured around 2 atm.The procedure was completed with another cre pulmonary 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 a visual examination of the returned complaint device found that the balloon and the catheter of the device did not have any damages.The balloon had some friction marks in the distal side.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located in the distal section on the body of the balloon.This does not confirm the reported event of balloon burst; however, the pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The pinhole problem is likely due to factors encountered during the procedure, such as the interaction between the balloon and the scope or any other surface during the procedure that could have created friction, resulting in the found failure of balloon pinhole.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.

• 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: 12181558
• Report Number: 3005099803-2021-03446
• Device Sequence Number: 16374870
• Product Code: KTI
• UDI-Device Identifier: 08714729456209
• UDI-Public: 08714729456209
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 01/18/2024
• Device Model Number: M00550320
• Device Catalogue Number: 5032
• Device Lot Number: 0026650626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR