MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) UROMAX ULTRA¿; DILATOR, CATHETER, URETERAL

Model Number	M0062251200
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the reported issue of seal compromised.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 uromax balloon kit was used in the ureter during a urinary tract dilation procedure performed on (b)(6) 2017.According to the complainant, during unpacking, they noted that the sterile bag of the inflator was already opened compromising the sterile barrier.Reportedly, this device was used to complete the procedure.There were no patient complications reported as a result of the 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 showed that the sterile packaging (tyvek) was partially opened and presented a crack on its original tray near the rear part of the gauge of the encore device.The noted defect can be addressed by (b)(4), which traced back to the design specifications which include but are not limited to the device requirements, testing processes, hazard analysis, implementation strategy, and user needs.Therefore, the most probable root cause of this complaint is design specification.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a uromax balloon kit was used in the ureter during a urinary tract dilation procedure performed on (b)(6) 2017.According to the complainant, during unpacking, they noted that the sterile bag of the inflator was already opened compromising the sterile barrier.Reportedly, this device was used to complete the procedure.There were no patient complications reported as a result of the event.The patient¿s condition at the conclusion of the procedure was reported to be good.

• Brand Name: UROMAX ULTRA¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6995925
• Report Number: 3005099803-2017-03304
• Device Sequence Number: 1354016
• Product Code: EZN
• UDI-Device Identifier: 08714729341277
• UDI-Public: 08714729341277
• Combination Product (Y/N): N
• PMA/510(K) Number: K980795
• 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): 10/18/2017

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: 08/31/2019
• Device Model Number: M0062251200
• Device Catalogue Number: 225-120
• Device Lot Number: 19934854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1