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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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COOK, INC. AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY Back to Search Results
Catalog Number AES-035145-DF
Device Problem Material Separation (1562)
Patient Problem Foreign body, removal of (2365)
Event Date 07/14/2014
Event Type  Injury  
Event Description
During the pcnl procedure, the blue coating on the amplatz extra stiff ptfe double flexible wire guide flaked off and entered the patient.The coating was removed by flushing the kidney with water and suctioned out.The procedure was completed with the same wire.No harm to the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
 
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Brand Name
AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE
Type of Device
OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
Manufacturer (Section D)
COOK, INC.
bloomington IN 47402
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47402
8123392235
MDR Report Key4017937
MDR Text Key4711212
Report Number1820334-2014-00347
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberAES-035145-DF
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/24/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/14/2014
Event Location Hospital
Initial Date Manufacturer Received 07/15/2014
Initial Date FDA Received08/08/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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