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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 BMK6F95
Medical Device Problem Codes Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/10/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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.The hospital discarded the device.
 
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that a benchmark 6f 071 delivery catheter (benchmark) was snapped in half upon removal from the dispenser hoop.The damaged benchmark was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new benchmark.
 
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Brand Name
BENCHMARK 6F 071 DELIVERY CATHETER
Common Device Name
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7095548
Report Number3005168196-2017-02180
Device Sequence Number13823807
Product Code DQY
UDI-Device Identifier00814548014111
UDI-Public00814548014111
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K142321
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/13/2017
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
Operator of Device Health Professional
Device Expiration Date08/17/2020
Device Catalogue NumberBMK6F95
Device Lot NumberF78730
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2017
Initial Report FDA Received Date12/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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