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

Model Number 12673-03

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 03/12/2018

Event Type  malfunction  

Event Description

At the end of the procedure, device failed and then required hand held pressure to be applied to patients left groin for an additional 20 minutes.Product had patient contact but no additional harm.Manufacturer response for proglide, (brand not provided) (per site reporter).Rep to pick up the product.

• Brand Name: PERCLOSE PROGLIDE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez road; temecula CA 92591
• MDR Report Key: 7637401
• MDR Text Key: 112317329
• Report Number: 7637401
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 7126041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2018
• Event Location: Operating Room
• Date Report to Manufacturer: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA