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

Catalog Number 14679-02

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during inspection of a starclose se vessel closure device prior to use, an incomplete seal of the pouch was observed.There was no patient contact.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported incomplete pouch seal was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.Packaging of 19 sterile devices from the account with the same lot number as the original complaint device were inspected for incomplete pouch seals and moisture and all units passed inspection.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: STARCLOSE VASCULARY CLOSURE SYSTEM
• Type of Device: VESSEL CLOSURE CLIP
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9649192
• MDR Text Key: 177176421
• Report Number: 2024168-2020-01050
• Device Sequence Number: 1
• Product Code: MGB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 14679-02
• Device Lot Number: 9073141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1