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	03/20/2020
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 that a passport dilation balloon catheter device was used in the left ureter during a uteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon inflated under 8atm; however, it exploded.The procedure was completed with another passport dilation balloon catheter device.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
Block h6: problem code 1074 captures the reportable event of balloon burst.Block h10: investigation results a visual examination of the returned complaint device found that the balloon was not folded which indicated that the balloon was subjected to positive pressure.No damage found on the shaft and tip of the device.A microscopic examination of the balloon found a longitudinal tear in the distal of the proximal balloon sleeve and extending distally across of the balloon material.This failure is likely due to factors or conditions related to difficult patient anatomy such as a high percentage of stenosis, calcification or tortuosity and it is possible that this would have contributed to a rupture in the balloon material.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.
Event or Problem Description
It was reported to boston scientific that a passport dilation balloon catheter device was used in the left ureter during a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon inflated under 8atm; however, it exploded.The procedure was completed with another passport dilation balloon catheter device.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.

• 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: 9947758
• Report Number: 3005099803-2020-01601
• Device Sequence Number: 19657229
• 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): 05/21/2020

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: 11/22/2021
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0022980957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR