MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 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	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 balloon dilatation catheter was used during an upper ureteroscopy (urs) procedure performed on (b)(6) 2018.According to the complainant, upon completion of the procedure, during withdrawal, the balloon would not deflate.It was reported that the inflation medium was eventually removed from the balloon.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.
Event or Problem Description
It was reported to boston scientific corporation that a passport balloon dilatation catheter was used during an upper ureteroscopy (urs) procedure performed on (b)(6) 2018.According to the complainant, upon completion of the procedure, during withdrawal, the balloon would not deflate.It was reported that the inflation medium was eventually removed from the balloon.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
A visual examination of the returned complaint device found that the balloon was torn longitudinally.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified inflation media that was present within the inflation lumen.There was also no kink or damage found along the shaft of the device.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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, there was no evidence that the device was used in a manner inconsistent with the labeled indications.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: PASSPORT¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7691495
• Report Number: 3005099803-2018-02206
• Device Sequence Number: 2580454
• Product Code: EZN
• UDI-Device Identifier: 08714729191872
• UDI-Public: 08714729191872
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 06/28/2018

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: 12/04/2020
• Device Model Number: M0062181100
• Device Catalogue Number: 218-110
• Device Lot Number: 21470176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR