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

Model Number M0062201090

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

This report pertains to one of two occlusion balloon catheters used in the same patient and procedure.It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occurred with the second occlusion balloon catheter.The procedure was completed with another occlusion balloon catheter.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 stable.

Manufacturer Narrative

Block h6: problem code 1074 captures the reportable issue of balloon burst.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of two occlusion balloon catheters used in the same patient and procedure.It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occurred with the second occlusion balloon catheter.The procedure was completed with another occlusion balloon catheter.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 stable.**correction** it was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.

• Brand Name: OCCLUDER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8586323
• MDR Text Key: 144272278
• Report Number: 3005099803-2019-02391
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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: 06/12/2020
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0023173580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1