MAUDE Adverse Event Report: ABBOTT VASCULAR STARCLOSE SE VASCULAR CLOSURE SYSTEM; VESSEL CLOSURE CLIP

Model Number 14679-01

Device Problems Unsealed Device Packaging (1444); Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

A starclose se was going to be used; however, it was opened and it didn¿t look right, and it didn¿t feel right.It was set aside and never used as it didn't look normal.It was not sealed right.There was a stain on the white part of the packaging and on the inner package looked like it had glue.The device was not used.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported ¿stain on the white part of the packaging and on the inner package looked¿ was confirmed.A review of the manufacturing records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported issue was concluded to be related to a potential product quality issue due to the moisture droplets present throughout the tray.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Type of Device: VESSEL CLOSURE CLIP
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10620699
• MDR Text Key: 209621188
• Report Number: 2024168-2020-08220
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: 08717648079467
• Combination Product (y/n): N
• PMA/PMN Number: P050007
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 14679-01
• Device Catalogue Number: 14679-01
• Device Lot Number: 0021941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1