MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER UROVAC¿ BLADDER EVACUATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0067301250
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	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 urovac bladder evacuator was unpacked on (b)(6) 2018.According to the complainant, during unpacking, a foreign body was noted on the device.It was reported that the sterile packaging was completely sealed and no damages were noted on the outer packaging.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 stable.
Additional Manufacturer Narrative
A urovac bladder evacuator bottle and the bottle cap were returned for analysis.The original pouch returned was completely open and no foreign matter was observed in pouch.Visual examination revealed that there was a foreign material stuck in one side of the bottle.The reported complaint that a foreign material was found on the side of the device was confirmed.The review and analysis of all available information failed to indicate a root cause and is therefore, undeterminable.A review of the device history record (dhr) was performed and no deviations were found.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 urovac bladder evacuator was unpacked on (b)(6) 2018.According to the complainant, during unpacking, a foreign body was noted on the device.It was reported that the sterile packaging was completely sealed and no damages were noted on the outer packaging.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 stable.

• Brand Name: UROVAC¿ BLADDER EVACUATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7356805
• Report Number: 3005099803-2018-00721
• Device Sequence Number: 1470992
• Product Code: KOG
• UDI-Device Identifier: 08714729753018
• UDI-Public: 08714729753018
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K880099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 01/15/2022
• Device Model Number: M0067301250
• Device Catalogue Number: 730-125S
• Device Lot Number: 21615506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1