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 Patient Involvement (2645)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign object on the device.During unpacking of an encore 26 inflation device, it was noted that there was a foreign object and contaminant on the inner wall of the tube of the device.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A foreign object (green) was inside in the encore barrel.The encore barrel was dissected in order to remove the foreign material.As soon as this was done, it was found that the foreign material (fm) was a piece of plastic tie wrap, 5 cm long.
Event or Problem Description
It was reported that there was foreign object on the device.During unpacking of an encore 26 inflation device, it was noted that there was a foreign object and contaminant on the inner wall of the tube of the device.The procedure was completed with another of the same device.No patient complications reported.

• 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: 9819276
• Report Number: 2134265-2020-02675
• Device Sequence Number: 19274291
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K955869
• 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): 06/02/2020

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: 07/07/2021
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0024069959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1