MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PASSPORT¿; DILATOR, CATHETER, URETERAL

Model Number	M0062181110
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Manufacturer report # 3005099803-2017-03004 pertains to the first passport balloon dilatation catheter, manufacturer report # 3005099803-2017-03005 pertains to the second passport balloon dilatation catheter and manufacturer report # 3005099803-2017-03006 pertains to the third passport balloon dilatation catheter.It was reported to boston scientific corporation that three passport balloon dilatation catheters were used during a procedure performed on an unknown date.According to the complainant, during the procedure, the balloons would not deflate.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.No patient complications were reported due to this event.

• Brand Name: PASSPORT¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6910180
• Report Number: 3005099803-2017-03004
• Device Sequence Number: 124623
• Product Code: EZN
• UDI-Device Identifier: 08714729154969
• UDI-Public: 08714729154969
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K941853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 05/09/2020
• Device Model Number: M0062181110
• Device Catalogue Number: 218-111
• Device Lot Number: 0020626602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1