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Model Number DSA-135-01
Device Problems Break (1069); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 03/04/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
According to the reporter, the distal portion of the cannula broke off and remained in patient. The procedure was attempted with a 135 degree catheter using a duct that had an estimated size of about 12-14 mm and ueus scope. The needle tip went in and there were some reduced visibility after the stylet was removed which they thought it was relatively normal or expected. The contrast was injected and there were some leakage of contrast outside the duct which was likely from the top fenestration. The stylet was pushed back in for position adjustment but there was resistance from about 10 cm before it would have been hubbed. The attempted adjustment seemed unsuccessful so the physician decided to pull the cannula back into the scope. After that, the stylet was successfully reinserted. The device was removed from the scope and they noticed an abnormal appearance of the distal tip. Approximately 90-95% of the fenestrated end sheered off into the duct with a somehow horseshoe shape. The customer stated that motions were careful with the scope and there was not much rotation of the cannula during the procedure, just a mm or two. The physician was uncertain as to what point of the procedure the detachment occurred. The patient was not reimaged after the procedure and was sent to a different facility for further work-up/treatment. The physician seemed to think that there was likely some bile leakage and the patient needed decompression of the biliary system. There was post procedural pain noted and the patient was given antibiotics. They also performed ercp (endoscopic retrograde cholangiopancreatography) to the patient. Based on the pre-ercp imaging, the broken portion of the catheter appeared to be partially within the duct but the majority was outside of the duct. There was free fluid outside of the duct compatible with biliary leak. They performed a percutaneous drainage and based on the ercp fluoroscopy/balloon sweep of the duct, the broken portion of the cannula was not identified within the duct. It was expected that the patient will be inpatient for somewhere around 3-5 days, and that direct visualization with a biliary camera may be performed at a follow-up ercp. The pre-procedure diagnosis was chronic abdominal pain, abnormal lst, dilated cbd (common bile duct). The name of the procedure performed to the patient was eus guided rendezvous. The removal of the needle was anticipated, the tip of the needle was still in the patient's biliary duct and the patient was aware of it.
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Brand NameBEACON
Manufacturer (Section D)
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer (Section G)
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
MDR Report Key9909014
MDR Text Key195389098
Report Number3004904811-2020-00006
Device Sequence Number1
Product Code FCG
UDI-Device Identifier10884521663527
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDSA-135-01
Device Catalogue NumberDSA-135-01
Device Lot NumberF2512493X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2020 Patient Sequence Number: 1