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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 G44155
Device Problems Peeled/Delaminated (1454); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
As reported, during an unspecified peripheral vascular procedure, the lining of a flexor ansel guiding sheath sheared off as another manufacturer's atherectomy device was removed from the sheath. The event occurred after use of the atherectomy device. 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. Upon return and initial evaluation of the device, the side-arm was also noted to be separated from the sheath.
 
Manufacturer Narrative
Device evaluation has begun; however, a conclusion is not yet available. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
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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
8128294891
MDR Report Key13119139
MDR Text Key285827065
Report Number1820334-2021-02755
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002441552
UDI-Public(01)00827002441552(17)241018(10)14285627
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG44155
Device Catalogue NumberKCFW-7.0-18/38-45-RB-ANL0-HC
Device Lot Number14285627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
PHILIPS PHOENIX 2.4 X 127
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