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	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 dilatation balloon catheter device was used in the left ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst under 8.5 atm.The procedure was completed with another passport dilatation balloon 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 dilatation balloon catheter device was used in the left ureter during a uteroscopy (urs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst under 8.5 atm.The procedure was completed with another passport dilatation balloon 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 a passport device was returned without the distal section of the balloon material.Visual examination identified that the balloon was not folded and had been subjected to positive pressure.A microscopic examination found a complete circumferential tear in the distal of the proximal balloon sleeve.A complete break of the shaft located distal of the proximal balloon sleeve was also noticed.There is no evidence from this investigation that indicates the device malfunctioned.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.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 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: 10078399
• Report Number: 3005099803-2020-01976
• Device Sequence Number: 3867104
• 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): 06/30/2020

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: 05/27/2022
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0023861828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR