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 Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 distal trachea during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon ruptured between 13.5 mm to 15mm stage of inflation.It was noted that it might be caused by the guidewire used with the device.Reportedly, saline leaked into the lungs and was suctioned.The patient was moved to recovery and the procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the distal trachea during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon ruptured between 13.5 mm to 15mm stage of inflation.It was noted that it might be caused by the guidewire used with the device.Reportedly, saline leaked into the lungs and was suctioned.The patient was moved to recovery and the procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results: a visual examination of the returned complaint device found that the balloon was noted to be burst.No damage found on the catheter of the device.Functional evaluation could not be performed due to the condition of the returned device.This failure is likely due to factors encountered during the procedure, such as the manner the device was handled and/or interaction with the scope, that could have affected its performance and its intended purpose.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: 9369549
• Report Number: 3005099803-2019-05583
• Device Sequence Number: 2224494
• Product Code: KTI
• UDI-Device Identifier: 08714729456186
• UDI-Public: 08714729456186
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: 06/30/2022
• Device Model Number: M00550300
• Device Catalogue Number: 5030
• Device Lot Number: 0024037843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR