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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 G56236
Device Problem Material Separation (1562)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Occupation: tech. 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 angiogram via access in the left groin, the tip of a flexor high-flex ansel guiding sheath separated upon removal of the device. Unknown wire guides, a balloon, and a stent were also used during the procedure. The complaint device had been in place for fort-five to sixty minutes. Resistance was not reported. An unknown wire was in the lumen of the sheath at the time of device removal and separation; however, the dilator was not reinserted prior to removal of the sheath. All pieces of the sheath were pulled out and the patient was stable. 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 Key11331779
MDR Text Key266677548
Report Number1820334-2021-00338
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002562363
UDI-Public(01)00827002562363(17)230805(10)13348998
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 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG56236
Device Catalogue NumberKCFW-6.0-35-55-RB-HFANL1-HC
Device Lot Number13348998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
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? Yes
Date Device Manufactured08/05/2020
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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