MAUDE Adverse Event Report: COOK INCORPORATED FLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION; 6FR X45 CM COOK ANSEL SHEATH

Model Number KCFW-6.0-18/38-45-RB

Device Problems Entrapment of Device (1212); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Alteration in Body Temperature (4568)

Event Date 04/26/2021

Event Type  Injury  

Event Description

A left lower extremity angiogram and intervention procedure was performed for worsening claudication and rest pain.An unexplained thrombus developed after atherectomy/ angioplasty of the superficial femoral artery which was lysed.The patient was discharged from our center without issues.However, several hours later he contacted dr.(b)(6) regarding pain in his foot with decreased temperature.He was instructed to report to the closest hospital (b)(6) where dr.(b)(6) performed an angiogram of his left leg showing thrombosis of his popliteal and tibial vasculature.Eventually, a small piece of plastic was retrieved from the posterior tibial artery, which represented the inside lining of a cook guiding sheath (45 cm).Despite multiple follow-up angiograms and lysis procedures over the next 24 hours, revascularization of his foot was not possible, requiring an amputation.Our center ivc reported this event to cook medical and also to cardiovascular systems, inc.(the maker of the atherectomy device diamondback).

• Brand Name: FLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION
• Type of Device: 6FR X45 CM COOK ANSEL SHEATH
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN 47404
• MDR Report Key: 11966083
• MDR Text Key: 256212072
• Report Number: 11966083
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/05/2021,05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: KCFW-6.0-18/38-45-RB
• Device Catalogue Number: G44154
• Device Lot Number: 13763460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2021
• Distributor Facility Aware Date: 04/26/2021
• Date Report to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2021
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 76 YR
• Patient Weight: 83