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U.S. Department of Health and Human Services

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

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COOK INCORPORATED FLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION 6FR X45 CM COOK ANSEL SHEATH Back to Search Results
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).
 
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Brand NameFLEXER CHECK-FLO INTRODUCER ANSEL MODIFICATION
Type of Device6FR X45 CM COOK ANSEL SHEATH
Manufacturer (Section D)
COOK INCORPORATED
bloomington IN 47404
MDR Report Key11966083
MDR Text Key256212072
Report Number11966083
Device Sequence Number1
Product Code DYB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKCFW-6.0-18/38-45-RB
Device Catalogue NumberG44154
Device Lot Number13763460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2021
Distributor Facility Aware Date04/26/2021
Event Location No Information
Date Report to Manufacturer04/05/2021
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/25/2021 Patient Sequence Number: 1
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