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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 BMK6F105BER130
Device Problem Fracture (1260)
Patient Problem Vasoconstriction (2126)
Event Date 06/08/2021
Event Type  malfunction  
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.
 
Event Description
The patient underwent a medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.After successful completion of the procedure, while removing the benchmark from the radial artery, the physician noticed the midshaft of the benchmark had fractured.Subsequently, the physician retracted the fractured portion of the benchmark back into the sheath and removed both the benchmark and sheath together as a system.It was also reported that the patient was administered with radial cocktail; however, a vasospasm had occurred while removing the benchmark.The procedure had ended at this point and no medical intervention was performed to treat the vasospasm.It was reported that the vasospasm was related to use of the benchmark.
 
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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
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12139750
MDR Text Key261361512
Report Number3005168196-2021-01498
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00814548014029
UDI-Public00814548014029
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 Physician
Type of Report Initial
Report Date 01/01/2005,07/08/2021
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 Date09/28/2023
Device Model NumberBMK6F105BER130
Device Catalogue NumberBMK6F105BER130
Device Lot NumberF100599
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 06/09/2021
Initial Date FDA Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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