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

Catalog Number 12673-03

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.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.The other three proglide devices are filed under separate medwatch manufacturing report numbers.

Event Description

It was reported that an arteriotomy closure of a common femoral artery, with no significant calcification, was attempted using four proglide devices with a 6f sheath after an interventional cerebral stenting procedure.Reportedly, during knot advancement, the knot locked and the suture broke for all four devices.No excessive force was applied; the sutures looked frayed after removal.Manual arterial compression 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: 7647943
• MDR Text Key: 112700774
• Report Number: 2024168-2018-05110
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 12673-03
• Device Lot Number: 8021641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Age: 63 YR
• Patient Weight: 103