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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY

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PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY Back to Search Results
Catalog Number 3MAXCKIT
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2022
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 was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc) and a penumbra engine canister (canister). During preparation for the procedure, the physician broke a 3maxc at the proximal end near the hub upon removal from its packaging hoop. The damage to the 3maxc occurred prior to use; therefore, the 3maxc was not used in the procedure. Then, the physician broke a 3maxc at the distal end in the target vessel. Subsequently, the physician aspirated the broken distal piece of the 3maxc out of the patient and into the canister. The procedure was completed using another 3maxc. There was no report of an adverse effect to the patient.
 
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Brand NamePENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
Type of DeviceNRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key15302721
MDR Text Key298714984
Report Number3005168196-2022-00395
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00814548019963
UDI-Public814548019963
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3MAXCKIT
Device Lot NumberF113127
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
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2022
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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