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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
Catalog Number KCFW-8.0-18/38-45-RB-ANL1-HC
Device Problem Material Separation (1562)
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
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 interventional procedure of the iliac, a flexor ansel guiding sheath separated from the hub at the middle of the sheath as the user was pulling back by the hub to adjust the device. The anatomy was very calcified, and resistance was reported upon removal of the sheath. The separated portion of the device was removed over an unknown wire guide without incident. The dilator was not in place at the time of separation. Another device of the same type was used to successfully complete the procedure. A section of the device did not remain inside the patient¿s 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 Key11362551
MDR Text Key233520966
Report Number1820334-2021-00378
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2021
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 Catalogue NumberKCFW-8.0-18/38-45-RB-ANL1-HC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
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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