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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); 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 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
Customer name and address
=
(b)(6). Occupation
=
(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 a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure, the dilator hub separated from a flexor high-flex ansel guiding sheath. The sheath and dilator were inserted and as the dilator was being removed, the hub separated, resulting in difficult removal of the dilator. 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 HIGH-FLEX 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 Key11100615
MDR Text Key227012538
Report Number1820334-2020-02397
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002477018
UDI-Public(01)00827002477018(17)230825(10)13388316
Combination Product (y/n)N
Reporter Country CodeAS
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 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberKCFW-12.0-35-45-RB-HFANL1-HC
Device Lot Number13388316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2020
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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