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	05/29/2019
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
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the right ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst during inflation.The procedure was completed with another passport balloon dilation 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 good.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the right ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon burst during inflation.The procedure was completed with another passport balloon dilation 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 good.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable event of balloon burst.Investigation result: a passport device was returned without the epidural inflation aid.A visual examination identified that the balloon was not folded and had been subjected to positive pressure.The returned device was attached to an encore inflation and positive pressure was applied when liquid was noted escaping from a pinhole in the balloon material.A microscopic examination found that no damage or issues with the tip.There is no evidence from this investigation that indicates the device malfunctioned.As no additional complaint information was provided the cause of the balloon pinhole cannot be determined.Therefore, taking into consideration the evaluation conducted at the complaint investigation site, the event information and the details of the complaint.Therefore the most probable root cause is cause not established.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: 8716228
• Report Number: 3005099803-2019-03186
• Device Sequence Number: 11380768
• 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): 08/01/2019

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: 09/26/2020
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0021183099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR