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

Catalog Number 14679-01

Device Problem Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related to circumstances of the procedure.A review of the lot history record and complaint history of the reported lot 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 the design, manufacture, or labeling of the device.

Event Description

It was reported that an arteriotomy closure of a common femoral artery was attempted using a starclose se device with a 5f sheath after a uterine fibroid embolization interventional procedure.Reportedly, the starclose se device was stuck in the patient.The safety release mechanism was used, but the starclose se device could not be removed.Counter tension and pulling was necessary to remove the starclose se device.Hemostasis was achieved by applying seven minutes of manual arterial compression.There was no reported adverse patient sequela.There was no clinically significant delay in the procedure or therapy.The physician is reportedly trained in the use of the starclose se device.No additional information was provided.

• 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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6138999
• MDR Text Key: 61243714
• Report Number: 2024168-2016-08471
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14679-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SHEATH: 5FHEPARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 74