MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number	M0062201090
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
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 an occluder ballon catheter was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in a procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the balloon burst.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Investigation results: a visual examination of the returned complaint device confirmed that the balloon burst.It was noticed that the proximal and distal bonds are continuous.Functional analysis could not be performed due to the returned condition of the balloon.There were no other issues noted with the device.This failure is likely due to factors and conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, th 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: OCCLUDER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8483233
• Report Number: 3005099803-2019-01610
• Device Sequence Number: 1955525
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 05/06/2020
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0023035830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1