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

Model Number	M0062181000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the kidney during a ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, physician tried to place the balloon on the guidewire; however, the tip of the balloon got bent.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a040609 captures the reportable event of balloon tip bent.Block h10: investigation result: the returned passport balloon dilatation catheter device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.No problems were identified to the balloon material.A visual and tactile evaluation found that the catheter shaft was kinked in multiple sections, indicating that excessive force being applied to the device.It was also observed that the tip of the device was damaged in several location, thereby confirming the reported event.The reported event was confirmed.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label.It was reported that the user attempted to load the device into the guidewire.The passport balloon device is not compatible and cannot be loaded into any guidewire.Additionally, the found damage to the shaft and tip is likely due to the excessive force being applied to the device in an attempt to load the device into the guidewire.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems traced to the user not following the manufacturer's instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the kidney during a ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, physician tried to place the balloon on the guidewire; however, the tip of the balloon got bent.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this 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: 13548714
• Report Number: 3005099803-2022-00814
• Device Sequence Number: 17439832
• Product Code: EZN
• UDI-Device Identifier: 08714729154921
• UDI-Public: 08714729154921
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 04/21/2023
• Device Model Number: M0062181000
• Device Catalogue Number: 218-100
• Device Lot Number: 0025457934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2020
• 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