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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICALCPS COURIER GUIDEWIREWIRE, GUIDE, CATHETER, RADIOLOGICAL; GUIDE, WIRE, ANGIOGRAPH

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ST. JUDE MEDICAL CPS COURIER GUIDEWIRE WIRE, GUIDE, CATHETER, RADIOLOGICAL; GUIDE, WIRE, ANGIOGRAPH   Back to Search Results
Catalog Number DS2G002
Event Date 07/06/2010
Event Type  Malfunction  
Event Description

Doctor was performing a dual chamber biventricular icd placement in cath lab and had placed the icd lead into veins over the lateral ventricle using a st. Jude courier guidewire. St. Jude rep was present in cath lab during this procedure. The lead was moved to find adequate pacing threshold and no phrenic nerve stimulation with 10-volt testing. Movement and active fixation of all leads were observed under fluoroscopy. No resistance was met when the guidewire was inserted. When retracting the guidewire from the coronary sinus, the tip of the guidewire was broken and could not be brought back. It was felt that this 1. 5 to 2 cm tip, which is in the distal portion of the vein, would not move from this place. Surgeon determined that attempted removal of the tip would be more risk to the patient than leaving the tip in the vein permanently. The tip was not removed from the patient. The procedure was completed with no complications except the broken tip of the guide wire, which is left in the distal portion of the vein. Patient was discharged home from the hospital in good condition the following day. ====================== health professional's impression======================this type of guidewire has never broken before during a procedure. The cause of the break is unknown. ====================== manufacturer response for icd guidewire, cps courier guidewire======================st. Jude rep was present during the procedure. St. Jude wants the device back for investigation of this event and upon completion of this report, device will be released to manufacturer for testing. Stated that this device has never broken before to their knowledge.

 
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Brand NameCPS COURIER GUIDEWIRE
Type of DeviceWIRE, GUIDE, CATHETER, RADIOLOGICAL; GUIDE, WIRE, ANGIOGRAPH
Manufacturer (Section F)
ST. JUDE MEDICAL
15900 valley view court
sylmar CA 91342
Manufacturer (Section D)
ST. JUDE MEDICAL
15900 valley view court
sylmar CA 91342
Device Event Key1803871
MDR Report Key1769199
Event Key1678263
Report Number1769199
Device Sequence Number1
Product CodeDQX
Report Source User Facility
Type of Report Initial
Report Date 07/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberDS2G002
Device LOT Number90015554
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2010
Device Age1 dy
Event Location Hospital
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 07/12/2010 Patient Sequence Number: 1
#TreatmentTreatment Date
NOT APPLICABLE
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