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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
Catalog Number BMK6F95BER120
Device Problems Collapse (1099); Device Damaged Prior to Use (2284); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2018
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
During preparation for a medical procedure, the hospital technician noticed that the mid-shaft of the benchmark 6f 071 delivery catheter (benchmark) was crushed upon removal from packaging.The damage to the benchmark was found prior to use and, therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.
 
Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
 
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Brand Name
BENCHMARK 6F 071 DELIVERY CATHETER
Type of Device
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7979440
MDR Text Key124152283
Report Number3005168196-2018-02065
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00814548014128
UDI-Public00814548014128
Combination Product (y/n)Y
PMA/PMN Number
K142321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/01/2005,09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/03/2019
Device Catalogue NumberBMK6F95BER120
Device Lot NumberF70941
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 09/20/2018
Initial Date FDA Received10/18/2018
Supplement Dates Manufacturer Received11/13/2018
Supplement Dates FDA Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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