MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number UNK PROGLIDE

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 12/01/2018

Event Type  Injury  

Event Description

This is a case example reported via an article.It was reported that an arteriotomy closure was attempted using proglide devices relative to a decannulation of veno-arterial extracorporeal membrane oxygenation procedure with a large bore sheath.Reportedly, there was an "improper operation with the perclose proglide device.Specifically, the operator pushed the knots and sutures deep under the arteriotomy site for release." acute ischemia occurred and a severe stenosis [occlusion] of the superficial femoral artery was noted.It was believed that the most probable cause of the stenosis was the improper operation of the proglide device.A drug-eluting stent was implanted to prevent ongoing lower limb ischemia.Additional information can be provided in the article titled: "outcomes comparison between percutaneous decannulation with perclose proglide and surgical decannulation of veno-arterial extracorporeal membrane oxygenation".

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3 - estimated date of event.D4: the udi is not known as the part and lot number were not provided.H6: medical device problem code 2017 -failure to follow steps / instructions.H6: medical device problem code 1494 - incorrect anatomy.The additional proglide device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19007935
• MDR Text Key: 338980033
• Report Number: 2024168-2024-03919
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK PROGLIDE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male