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

Model Number	M0062181300
Medical Device Problem Codes	Burst Container or Vessel (1074); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
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
It was reported to boston scientific corporation that a passport dilatation balloon device was used in the ureter in a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.It was reported that a piece of the balloon was removed from the ureter and it was also noted that the end of the balloon wire was frayed.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.
Additional Manufacturer Narrative
Correction: block h6 (device code) block h10 block h6: problem code 1074 captures the reportable event of balloon burst.Problem code 2907 captures the reportable event of balloon detached.Problem code 2907 captures the reportable event of balloon tip detached.Block h10: 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
It was reported to boston scientific corporation that a passport dilatation balloon device was used in the ureter in a procedure perforned on (b)(6), 2020.According to the complainant, during the procedure, the balloon burst.It was reported that a piece of the balloon was removed from the ureter and it was also noted that the end of the balloon wire was frayed.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: 9682857
• Report Number: 3005099803-2020-00337
• Device Sequence Number: 3171570
• 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,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: M0062181300
• Device Catalogue Number: 218-130
• Device Lot Number: 0024574719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention