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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON EUS ACCESS SYSTEM; KIT, NEEDLE, BIOPSY

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COVIDIEN LP BARRX BEACON EUS ACCESS SYSTEM; KIT, NEEDLE, BIOPSY Back to Search Results
Model Number DSA-135-01
Device Problem Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the physician tried to gain access to the patient's common bile duct during the rendezvous procedure but they could not pass the guide wire through the stricture and it kept going toward the hilum.The patient had a distal biliary obstruction with a common duct diameter of around 12 mm.They tried to put the stylet back into the cannula to make the hook straight again before removing it but was unable to insert cannula to the end.The cannula would not go back into the device and they could not remove without the tip being hooked.The incident occurred on first pass.Ercp (endoscopic retrograde cholangiopancreatography) was attempted just prior to the rendezvous attempt, but ercp cannulation had failed.The physician also attempted to use a 90 degree access device, the guide wire inserted but it again kept going into the hilum.The guide wire was removed and the stylet was re-inserted prior to the removal of the 90 degree catheter.At no point did the guide wire successfully make the turn and proceed antegrade.There was no immediate complications noted.A ct scan was performed the following day as part of pancreatic ca staging, and biliary leak was identified.The leak was pretty big and they performed an ir (interventional radiologist) guided percutaneous drain.There were no other relevant comorbidities were reported and no abnormal anatomy or scope tortuosity was present.The physician suspected that the leak was related to multiple attempts and since system was still pressurized without drainage of obstruction at the end of procedure.The rendezvous procedure was not completed.There was no fracture/detachment of the cannula during this case.There was no user harm.
 
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Brand Name
BEACON EUS ACCESS SYSTEM
Type of Device
KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer (Section G)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key10260212
MDR Text Key205577865
Report Number3004904811-2020-00019
Device Sequence Number1
Product Code FCG
UDI-Device Identifier10884521663527
UDI-Public10884521663527
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2020
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? Yes
Device Operator Health Professional
Device Model NumberDSA-135-01
Device Catalogue NumberDSA-135-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2020
Initial Date FDA Received07/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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