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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number G48003
Device Problem Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. 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 arteriogram of the lower leg via femoral access, a micropuncture transitionless stiffened cannula access set's coaxial system split. The user was able to insert the needle and wire guide into the heavily calcified and scarred groin; however, upon insertion of the coaxial system, both the inner and outer cannulas bent and broke, splitting longitudinally. Resistance was reported upon both insertion and removal of the device. The wire was still in place and the entire complaint device was removed over the wire, abandoning the access site. Another device of the same type was used to access an alternate site and the procedure was completed successfully. Although the patient had undergone multiple previous procedures via groin access, a closure device was not in place. 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 NameMICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
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 Key11362480
MDR Text Key234430764
Report Number1820334-2021-00377
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002480032
UDI-Public(01)00827002480032(17)230924(10)13451443
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2021
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 NumberG48003
Device Catalogue NumberMPIS-401-10.0-SC-NT-SST
Device Lot Number13451443
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 Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2020
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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