MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-03

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (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 reported difficulties and subsequent treatment appear to be related to an interaction of the device with patient anatomy due 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 manufacture, design or labeling.The other proglide device referenced is filed under a separate medwatch manufacturing report number.

Event Description

It was reported that an arteriotomy closure of the mildly calcified right common femoral artery was attempted using two proglide devices with a 5f sheath after a diagnostic procedure.Reportedly, a suture break occurred with both devices.Another proglide device was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• 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: 7509655
• MDR Text Key: 108083906
• Report Number: 2024168-2018-03527
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: 08717648013089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960043
• 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: 05/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12673-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/12/2018
• 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
• Patient Outcome(s): Required Intervention