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

Model Number	M0062181100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the upper ureter during an upper ureteroscopy (urs) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon would not deflate.Reportedly, the device was cut using scissors.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Problem code 1149 captures the reportable issue of balloon failed to deflate.Visual examination of the returned complaint device revealed that the catheter dissected and the distal section of the device containing the balloon and tip had not been returned for analysis.Multiple kinks were also noted along the length of the catheter.It is possible that all damages could be caused by an excessive handling of the customer, and it is also possible that some conditions related to the procedure during the use of the device could have affected its performance and its intended purpose, leading to the observed failures and the reported adverse event.However, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.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 from the information available this device was used per the directions.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used in the upper ureter during an upper ureteroscopy (urs) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon would not deflate.Reportedly, the device was cut using scissors.The procedure was completed with another passport balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: PASSPORT
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8160990
• Report Number: 3005099803-2018-61962
• Device Sequence Number: 2288029
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 05/13/2021
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 0022113743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR