MAUDE Adverse Event Report: AV-TEMECULA-CT STARCLOSE SE VASCULAR CLOSURE SYSTEM; IMPLANTABLE CLIP

Catalog Number 14679-01

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during unpackaging of a starclose se device, the secondary package was partially open.Sterility of the starclose se device was breached.The device was used for demo purposes and was then discarded, there was no patient involvement.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for evaluation.Without the lot number and packaging returned for analysis a conclusive cause for the reported breached packaging cannot be determined.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Type of Device: IMPLANTABLE CLIP
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8229576
• MDR Text Key: 132507039
• Report Number: 2024168-2019-00216
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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 Catalogue Number: 14679-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1