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

Model Number	3040
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the opening seal flap part was torn off.A encore 26 inflation device was selected for use.It was noted that the opening seal was not peeled of, but the flap part was torn off indicating that the seal of the product box was found to be damaged.No complications reported.
Additional Manufacturer Narrative
E1: initial reporter email- (b)(6).E1: initial reporter title - sr specialist, customer center, customer srv, ops device evaluated by manufacturer: the device was returned for analysis.Initial condition unit returned with its original unopened box batch 24359925.The returned device matches with upn provided by the customer.Visual inspection performed.The carton (box): the device was returned on its original package (box).The closure strip was present and still intact.A damage (torn off ) was noted in one of the corners of the box.
Event or Problem Description
It was reported that the opening seal flap part was torn off.A encore 26 inflation device was selected for use.It was noted that the opening seal was not peeled of, but the flap part was torn off indicating that the seal of the product box was found to be damaged.No 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: 9672898
• Report Number: 2134265-2020-00488
• Device Sequence Number: 319429
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: Other
• Device Expiration Date: 09/01/2021
• Device Model Number: 3040
• Device Catalogue Number: 3040
• Device Lot Number: 0024359925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1