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

Catalog Number 12673-03

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2016

Event Type  malfunction  

Event Description

Two proglide perclose devices utilized during a transcatheter aortic valve implantation surgery.One device did not work with no immediate consequence noted.

• Brand Name: PERCLOSE PROGLIDE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez road; temecula CA 92591
• MDR Report Key: 5928402
• MDR Text Key: 53917191
• Report Number: 5928402
• 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: Other
• Type of Report: Initial
• Report Date: 08/01/2016,08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 12673-03
• Device Lot Number: 6042041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR