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	12/19/2018
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
It was reported to boston scientific corporation that a passport balloon dilation catheter was used in the upper ureter during an upper urs procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon burst inside the patient.Reportedly, the transparent balloon portion of the device that detached was not retrieved and was left to pass naturally.The procedure was completed with another passport balloon dilation catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilation catheter was used in the upper ureter during an upper urs procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon burst inside the patient.Reportedly, the transparent balloon portion of the device that detached was not retrieved and was left to pass naturally.The procedure was completed with another passport balloon dilation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable event of balloon burst.A visual examination of the returned complaint device found that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Functional analysis was performed by attaching the device to an encore inflation unit.Positive pressure was applied and leak was noted on the balloon due to a pinhole located at the proximal of the distal balloon bond.No other issues were noted on the device.This failure is likely due to an existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.Therefore, the most probable root cause is adverse event related to patient condition.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 for use (dfu)/product label.

• 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: 8228815
• Report Number: 3005099803-2018-62513
• Device Sequence Number: 13970597
• 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): 02/20/2019

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: 03/05/2021
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0021822945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1
• Patient Age: 62 YR