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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G29982
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during an unspecified renal procedure, the hub of a flexor ansel guiding sheath separated from the device upon removal from the patient. Removal was difficult and resistance was reported. The patient had fibrotic tissue at the superficial femoral artery access site and proximal right iliac from a previous open femoral bypass surgery. An unknown renal stent and guidewires were used during the procedure, and heparin was given. The sheath was inserted to 45-centimeters. The dilator was not in place upon removal of the device or at the time of separation. Blood loss was reported; however, no intervention was required to treat blood loss. The device was successfully removed from the patient, who is reportedly "ok". A section of the device did not remain inside the patients body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameFLEXOR ANSEL GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11359583
MDR Text Key243980981
Report Number1820334-2021-00370
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002299825
UDI-Public(01)00827002299825(17)230812(10)13363201
Combination Product (y/n)N
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG29982
Device Catalogue NumberKCFW-6.0-18/38-45-RB-ANL1-HC
Device Lot Number13363201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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