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Adverse Event Report

BALLARD MEDICAL PRODUCTS BALLARD MEDICAL PRODUCTS ERCP CANNULA   back to search results
Patient Outcome  Required Intervention;
Event Description

The radiopaque ring from a ballard ercp cannula has come off the cannula tip and is on a guidewire which is threaded in this pt's papilla. This is the second time that the radiopaque metal ring fell off a cannula today while working in ercp. The first incident is when physician pulled out the cannula to groom the tip (give it more or less of a bend). The ring came off in hand. The next cannula worked well. In the next case, while doing an exchange of guidewire for cannula, the metal ring came off the cannula as the physician retracted the cannula and nurse advanced the guidewire. Photo was made of that ring as it slid down the guidewire. Briefly wedged the metal ring in the papilla but able to abort the procedure and remove the cannula and guidewire and have the metal ring from the tip of the cannula safely pass into the bowel of the pt to pass with stool. Since the only cannulas on hand were this series number, they aborted any further intervention. Rptr feels this run of production must be defective. Rptr suggests product pulled off the market before an incident occurs and the consumer product safety commission is notified.

 
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Brand NameBALLARD MEDICAL PRODUCTS
Type of DeviceERCP CANNULA
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
*
Device Event Key385955
MDR Report Key390406
Event Key375017
Report NumberMW1024822
Device Sequence Number1
Product CodeGBZ
Report Source Voluntary
Report Date 04/18/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 06, 2009

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