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

Model Number 25335

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2022

Event Type  malfunction  

Event Description

It was reported that loss of sterility occurred.An encore-26 inflation device was selected for use.During preparation, when the pressure pump package was unpacked, it was noted that the sterile package was damaged.The seal was not compromised but there was a loss of device sterility.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

The device was returned for analysis outside the original packaging.No visual damaged were noted.The unit was returned with a label which contained the proper lot and upn for the reported issue.

Event Description

It was reported that loss of sterility occurred.An encore-26 inflation device was selected for use.During preparation, when the pressure pump package was unpacked, it was noted that the sterile package was damaged.The seal was not compromised but there was a loss of device sterility.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.Device evaluated by manufacturer: the device was returned for analysis.Unit returned outside the original packaging.No visual damages were noticed on the device.Uni returned with a label that contains the proper lot and upn reported.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16197569
• MDR Text Key: 308374251
• Report Number: 2124215-2023-00705
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0027677341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 56 KG