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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 BMK6F105M
Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
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 coil embolization procedure in the right radial and subclavian artery using a benchmark 6f 071 delivery catheter (benchmark). During the procedure, the physician experienced resistance while advancing a benchmark through a probable vasospasm of the radial artery. Subsequently, it was noticed that the benchmark was punctured and leaking at the proximal one third. The procedure was completed using the same benchmark due to the approach of the intervention being complex. 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 Key12072094
MDR Text Key259227885
Report Number3005168196-2021-01420
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
K142321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBMK6F105M
Device Catalogue NumberBMK6F105M
Device Lot NumberF102397
Was Device Available for Evaluation? Yes
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 Received05/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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