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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC. PIG 4.0F X .036 X 90CM BEACON TIP ROYAL FLUSH PLUS HIGH FLOW CATHETER

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COOK INC. PIG 4.0F X .036 X 90CM BEACON TIP ROYAL FLUSH PLUS HIGH FLOW CATHETER Back to Search Results
Catalog Number G09407
Device Problems Wire (430); Component Missing (2306); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2015
Event Type  Other  
Event Description

During an endovascular (angiogram) case, the grand slam wire was retracted by doctor from the patient's vessel (anterior tibial). When the wire was fully retrieved from the patient's left lower extremity, doctor noticed the tip of the wire was missing. An x-ray was taken of the affected extremity and proved the missing piece of wire was inside the vessel. Per doctor, no intervention was indicated due to the vessel being occluded before introduction of the wire.

 
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Brand NamePIG 4.0F X .036 X 90CM BEACON TIP ROYAL FLUSH PLUS HIGH FLOW CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
COOK INC.
750 daniels way
bloomington IN 47404
MDR Report Key4869423
MDR Text Key6041556
Report NumberMW5043230
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Device EXPIRATION Date07/01/2016
Device Catalogue NumberG09407
Device LOT Number434987
Is The Reporter A Health Professional? Yes

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