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

Model Number	M0062181100
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: 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.A microscopic examination identified a balloon pinhole and an inflation test could not be carried out due to the balloon pinhole.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No issues were noted with the tip of the device.This failure is likely due to factors or conditions related to difficult patient anatomy such as 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 instruction for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, the balloon was not inflated.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable 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: 11981939
• Report Number: 3005099803-2021-02800
• Device Sequence Number: 4490875
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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: 03/31/2023
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0025429401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR