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

Model Number	M00550350
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
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 right main stem during a bronchoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon inflation, the balloon burst at the recommended pressure for the dilation size.Reportedly, the balloon was retrieved with biopsy forceps.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
Problem code 1074 captures the reportable issue of balloon burst.Problem code 2907 captures the reportable issue of balloon material detached.Investigation results: a visual examination of the returned complaint device revealed the catheter was found broken near the balloon hub and the balloon portion of the device was not returned.Functional analysis was unable to be performed due to the returned condition of the device.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the right main stem during a bronchoscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, upon inflation, the balloon burst at the recommended pressure for the dilation size.Reportedly, the balloon was retrieved with biopsy forceps.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
• MDR Report Key: 8583047
• Report Number: 3005099803-2019-02310
• Device Sequence Number: 14041853
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0022268354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/26/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention