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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 BMK6F105MBER130
Medical Device Problem Codes Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/05/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the benchmark 6f 071 delivery catheter (benchmark) was kinked upon removal from the packaging.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 Key6756956
Report Number3005168196-2017-01309
Device Sequence Number13825616
Product Code DQY
UDI-Device Identifier00814548014050
UDI-Public00814548014050
Combination Product (Y/N)N
Initial Reporter StateVA
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) 07/10/2017
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 Date03/21/2020
Device Catalogue NumberBMK6F105MBER130
Device Lot NumberF75135
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2017
Initial Report FDA Received Date08/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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