MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY UROMAX ULTRA¿; DILATOR, CATHETER, URETERAL

Model Number	M0062251210
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon kit was used during a procedure performed on (b)(6) 2017.According to the complainant, during procedure, while unpacking there was a hair found inside of the sterile packaging.The procedure was completed with another uromax ultra balloon kit.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be unharmed and stable.
Additional Manufacturer Narrative
Investigation result: visual examination of the returned device revealed that the inner pouch was opened and sterility was not intact, with the heat seal visible on the pouch.Foreign matter was identified attached to a corner of the uromax device tray and microscopically inspected and was determined to be a long human hair.As the device was received with the packaging having already been opened, the root cause as to where and when the hair came in contact with the packaging is undetermined.Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.There was no evidence to suggest that the device was used in a manner inconsistent with the labeled indications.A search of the complaint database revealed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon kit was used during a procedure performed on (b)(6) 2017.According to the complainant, during procedure, while unpacking there was a hair found inside of the sterile packaging.The procedure was completed with another uromax ultra balloon kit.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be unharmed and stable.

• Brand Name: UROMAX ULTRA¿
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6743678
• Report Number: 3005099803-2017-02154
• Device Sequence Number: 10953158
• Product Code: EZN
• UDI-Device Identifier: 08714729341284
• UDI-Public: (01)08714729341284(17)20190930(10)19990525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K980795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

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: 09/30/2019
• Device Model Number: M0062251210
• Device Catalogue Number: 225-121
• Device Lot Number: 19990525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1