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

Model Number M00550350

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used above the carina area during a dilation of trachea procedure performed on (b)(6) 2020.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.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: device code 1074 addresses the reportable event of balloon burst.Block h10: investigation results: a visual examination of the returned complaint device confirmed that the balloon was ruptured.No other issues were noted to the returned device.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the manner in which the device was handled and manipulated during preparation, initial set-up or during procedure, that could have affected device 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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used above the carina area during a dilation of trachea procedure performed on (b)(6) 2020.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.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CRE PULMONARY
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9841781
• MDR Text Key: 191278280
• Report Number: 3005099803-2020-00895
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: 08714729456230
• Combination Product (y/n): N
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Device Lot Number: 0024796118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1