MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROGLIDE SUTURE MEDICATED CLOSURE SYSTEM; DEVICE, HEMOSTASIS, VASCULAR

Lot Number 2111141

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Perclose proglide fractured during use.

• Brand Name: PERCLOSE PROGLIDE SUTURE MEDICATED CLOSURE SYSTEM
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 16386703
• MDR Text Key: 309779298
• Report Number: MW5114989
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2111141
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female