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

Model Number	M0062181100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test was performed and it was noticed that the balloon had a pinhole located at the distal section of the balloon material, thereby confirming the reported event of balloon leak.No kinks or damaged noted along the shaft of the device.No other problems were noted during product analysis.The device may have encountered difficult patient anatomy such as a high percentage of stenosis, calcification or tortuosity and it is possible that the device had an interaction with a stone which could have possibly affected the device 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.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the contrast agent continued to drain out.The procedure was completed with another passport balloon dilatation catheter.Note: a photo was submitted by the customer showing a deflated balloon.No visible problem was noted to the catheter.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test was performed and it was noticed that the balloon had a pinhole located at the distal section of the balloon material, thereby confirming the reported event of balloon leak.No kinks or damaged noted along the shaft of the device.No other problems were noted during product analysis.The device may have encountered difficult patient anatomy such as a high percentage of stenosis, calcification or tortuosity and it is possible that the device had an interaction with a stone which could have possibly affected the device 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.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the contrast agent continued to drain out.The procedure was completed with another passport balloon dilatation catheter.Note: a photo was submitted by the customer showing a deflated balloon.No visible problem was noted to the catheter.There were no patient complications reported as a result of this event.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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12962237
• Report Number: 3005099803-2021-06363
• Device Sequence Number: 1854686
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 06/09/2022
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0023924540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown