MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROGLIDE; DEVICE, HEMOSTASIS, VASCULAR

Model Number 12673-03

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Event Description

At the end of the transcatheter aortic valve replacement (tavr) procedure the proglide device had what the dr.Called a missed deployment - the proglide got stuck inside the patient.In order to remove the proglide, surgeon had to do a small cut down.Product had patient contact but no harm.Manufacturer response for proglide, (brand not provided) (per site reporter).The entire lot number was picked up by field rep.

• Brand Name: PERCLOSE PROGLIDE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 7613774
• MDR Text Key: 111490933
• Report Number: 7613774
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 8042542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1