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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER DQY

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PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER DQY Back to Search Results
Model Number BMK6F95BER120
Device Problems Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  Injury  
Manufacturer Narrative
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
 
Event Description
The patient was undergoing a medical procedure in the venous sinus using a benchmark 6f 071 delivery catheter (benchmark). During the procedure, the physician advanced the benchmark to the target vessel using a guidewire; however, he decided to replace the guidewire with a longer guidewire. While advancing the guidewire into the benchmark, the physician felt resistance at the distal end of the benchmark and therefore decided to retract the benchmark out. While retracting, the physician noticed several black dots on the images under fluoroscopy and realized that the tip of the benchmark was broken and unraveled. The physician then used a stent retriever to retrieve the tip of the benchmark successfully. The physician aborted the procedure at this point. There was no report of an adverse effect to the patient.
 
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Brand NameBENCHMARK 6F 071 DELIVERY CATHETER
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12411462
MDR Text Key269469220
Report Number3005168196-2021-01942
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K142321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBMK6F95BER120
Device Catalogue NumberBMK6F95BER120
Device Lot NumberF98037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2020
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: 09/01/2021 Patient Sequence Number: 1
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