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

Model Number 3040

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2019

Event Type  malfunction  

Event 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.

Event 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.

Manufacturer Narrative

Device evaluated by 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.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8691418
• MDR Text Key: 147738028
• Report Number: 2134265-2019-06499
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729177029
• UDI-Public: 08714729177029
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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
• Device Operator: 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 Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85