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

Model Number	M0062181100
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During preparation, it was noticed that the balloon had a hole.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.Note: the photos submitted by the customer shows the balloon outside the patient and it was observed that the distal tip of the catheter was kinked.
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 preparation, it was noticed that the balloon had a hole.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.Note: the photos submitted by the customer shows the balloon outside the patient and it was observed that the distal tip of the catheter was kinked.Additional information received on february 17, 2022: the intended anatomy location of the procedure was the orifice.
Additional Manufacturer Narrative
Block h6: medical device code a040609 captures the reportable event of balloon tip bent.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon was torn longitudinally from the proximal of the tip extending proximal across the balloon material.The tip of the device was found to be kinked at more than one location, thereby confirming the reported event.No problems were identified to the balloon material.A visual and tactile analysis were performed to the catheter shaft and revealed that there was no problem found to the shaft of the catheter.It is possible that the interaction between the balloon with a foreign or sharp object could have caused the balloon tear.Additionally, the found damage to the tip of the device is likely due to an excessive force being applied to the device during preparation.Taking all available information into consideration, the most probable root cause is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.

• 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: 13259232
• Report Number: 3005099803-2022-00101
• Device Sequence Number: 16569396
• 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,Followup
• Report Date (Section B): 03/08/2022

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: 05/20/2023
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0025526369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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