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

Catalog Number 12673-03

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Sticking (1597)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 05/29/2018

Event Type  Injury  

Event Description

Impella/ptca, perclose device placed in left common femoral artery.Foot on device could not be retracted.Pt in extreme pain.Taken to surgery.Perclose was in common femoral artery and foot of device open, stuck and could not retrieve.Caused significant laceration femoral artery requiring repair.

• Brand Name: PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA
• MDR Report Key: 7596211
• MDR Text Key: 111047397
• Report Number: MW5077812
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12673-03
• Device Lot Number: 604142
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86