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

Model Number	M0062181300
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the complaint device revealed that the device was returned with the balloon protector still on the delivery system.The balloon protector had been retracted proximal to the balloon material and the balloon was unfolded and had been subjected to positive pressure.Functional analysis was performed, and the balloon was inflated; however, the balloon would not hold pressure due to a pinhole found in the balloon distal to the proximal balloon bond.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 there is no evidence that the device was used in a manner inconsistent with the labeling.
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) 2018.According to the complainant, during preparation, it was noted that the balloon was not able to be inflated due to a tear.The procedure was completed with another passport dilation balloon catheter.There were no patient complications reported as a result of the event.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: PASSPORT KIT
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8173587
• Report Number: 3005099803-2018-61979
• Device Sequence Number: 1459595
• Product Code: EZN
• UDI-Device Identifier: 08714729042594
• UDI-Public: 08714729042594
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 12/18/2018

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: 12/31/2020
• Device Model Number: M0062181300
• Device Catalogue Number: 218-130
• Device Lot Number: 0022006714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1