MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PASSPORT; DILATOR, CATHETER, URETERAL

Model Number	M0062181100
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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
This report pertains to one of two passport balloon dilatation catheters used during the same procedure.It was reported to boston scientific corporation that two passport balloon dilatation catheter devices were used in the ureter duing a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occured on the second passport balloon dilatation catheter.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable event of balloon burst.Block h10: investigation results: visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a longitudinal tear in the balloon material, proximal of the distal balloon bond and extending proximally across the balloon material.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 as the device was handled, and/or the interaction with the scope.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.
Event or Problem Description
Note: this report pertains to one of two passport balloon dilatation catheters used during the same procedure.It was reported to boston scientific corporation that two passport balloon dilatation catheter devices were used in the ureter duing a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst.The same issue occured on the second passport balloon dilatation catheter.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.

• Brand Name: PASSPORT
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8627571
• Report Number: 3005099803-2019-02583
• Device Sequence Number: 2257831
• Product Code: EZN
• UDI-Device Identifier: 08714729191872
• UDI-Public: 08714729191872
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941853
• 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: 10/23/2021
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0022836959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/21/2019
• 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