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 04/16/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Correction - device return status changed from returning to not returning.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

It was reported that after the outer package of starclose se device was opened it was found that the sterile barrier of the inner package was unsealed.The device was not used.Another starclose se device with the same lot was used without an issue.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).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.

• 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 462
• Manufacturer (Section G): REDWOOD CITY, CA USA REG# 2953144; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3798853
• MDR Text Key: 12084372
• Report Number: 2024168-2014-02917
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2014

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: 08/31/2015
• Device Catalogue Number: 14679-01
• Device Lot Number: 31021K1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 69 YR