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

Model Number	M0062181010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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 the two passport dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two passport dilatation balloon devices were used in a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, both of the balloon burst.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9641371
• Report Number: 3005099803-2020-00154
• Device Sequence Number: 1964836
• Product Code: EZN
• UDI-Device Identifier: 08714729042594
• UDI-Public: 08714729042594
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/29/2020

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: 04/13/2022
• Device Model Number: M0062181010
• Device Catalogue Number: 218-130
• Device Lot Number: 0024001751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1