MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number	3040
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	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported facility name: (b)(6) hospital.
Event or Problem Description
It was reported that foreign material was found on the device.An encore 26 inflation device was selected for use.During unpacking, it was noted that dirt was found on the device.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that foreign material was found on the device.An encore 26 inflation device was selected for use.During unpacking, it was noted that dirt was found on the device.The procedure was completed with another of the same device.No patient complications were reported.Device evaluated by mfr: during the visual inspection the encore was found with a white stain on the side of the device, the stain was noted to be on the inside of the clear housing and on the outside of the barrel.The stain did not obstruct the graduation marks in the barrel.No other issues noted.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7944097
• Report Number: 2134265-2018-61510
• Device Sequence Number: 1355779
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 06/24/2020
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0022294189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1