MAUDE Adverse Event Report: COOK MEDICAL ANSEL 6 FR X 45 CM; CATH LAB SHEATH

Catalog Number G44154

Device Problems Device, or device fragments remain in patient (1527); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/08/2016

Event Type  Injury  

Event Description

Pt with history of cad, previous cabg, was admitted with a nstemi.She underwent cardiac catheterization via right femoral artery.At end of case, femoral sheath could not be removed, likely stuck in surrounding scar tissue overlying femoral artery.Part of sheath separated while trying to remove it, leaving the integrated wire hanging out from the skin and rest of sheath in groin.Pt was taken to operating room to remove residual sheath via cut down of right common femoral artery and repair arteriotomy site.Sheath removed.Pt is stable.

• Brand Name: ANSEL 6 FR X 45 CM
• Type of Device: CATH LAB SHEATH
• Manufacturer (Section D): COOK MEDICAL ; po box 4195 ; bloomington IN 47402 4195
• MDR Report Key: 6176446
• MDR Text Key: 62476212
• Report Number: 6176446
• Device Sequence Number: 1
• Product Code: DYB
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: G44154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2016
• Date Report to Manufacturer: 11/14/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 57 YR