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

Model Number 12673-03

Device Problem Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

Perclose closure device failed when attempting to close right femoral artery.Portion of closure device became lodged in the right superficial femoral artery (sfa), requiring patient to be taken to the or.Possible device failure vs.Sub-optimal deploying technique.

• Brand Name: PERCLOSE PROGLIDE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside dr.; santa clara CA 95054
• MDR Report Key: 6471531
• MDR Text Key: 72132305
• Report Number: 6471531
• 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: 03/23/2017,04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 12673-03 6102741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR