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

Model Number M0062201090

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

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 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 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.

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
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8483233
• MDR Text Key: 140921266
• Report Number: 3005099803-2019-01610
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (y/n): N
• PMA/PMN Number: K133750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/04/2019
• Patient Sequence Number: 1