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

Model Number	3040
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the aseptic packaging was damaged.An encore 26 inflation device was selected for use.Upon unpacking, it was noted that the aseptic packaging of the device was damaged.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The device was returned for analysis.An encore device with its original opened box and its original tray was returned for this complaint.The tray was returned with its tyvek partially open, there is some residues of tyvek over the edges of the tray in the seal area.
Event or Problem Description
It was reported that the aseptic packaging was damaged.An encore 26 inflation device was selected for use.Upon unpacking, it was noted that the aseptic packaging of the device was damaged.The procedure was completed with another of the same device.No complications reported and the patient is stable.

• 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: 8688772
• Report Number: 2134265-2019-06501
• Device Sequence Number: 19587992
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/30/2019

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: 07/20/2019
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0020912603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85