MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ZELANTEDVT; CATHETER, EMBOLECTOMY

Model Number 45027

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

It was reported that internal package was already opened.An angiojet zelantedvt was selected for use.However, during unpacking, it was noted that the internal package was already opened.The device was not used and a different device was pulled to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a zelante thrombectomy system.The product pouch and tray packaging were visually inspected.The product pouch was opened by the facility, as the bsc seal was intact and the tyvek seal was opened.The batch number on the returned packaging was 23675595.The tyvek on the tray was noticed to be half open.The tray and tyvek were inspected, and it was found that the seal on the unsealed portion of the tray was incomplete.The packaging was not sealed completely when it left manufacturing facility.Inspection of the remainder of the packaging presented no damage or other irregularities.

Event Description

It was reported that internal package was already opened.An angiojet zelantedvt was selected for use.However, during unpacking, it was noted that the internal package was already opened.The device was not used and a different device was pulled to complete the procedure.No patient complications were reported.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9468261
• MDR Text Key: 176393194
• Report Number: 2134265-2019-15712
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (y/n): N
• PMA/PMN Number: K151313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0023675595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1