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 Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem 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.
Additional 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.

• Brand Name: OCCLUDER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8582222
• Report Number: 3005099803-2019-02392
• Device Sequence Number: 296294
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1