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Catalog Number PNML6F088804
Device Problems Flaked (1246); Material Integrity Problem (2978)
Patient Problems Edema (1820); Granuloma (1876); Headache (1880); Hematoma (1884); Intracranial Hemorrhage (1891); Weakness (2145); Dizziness (2194); Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)
Event Date 01/18/2016
Event Type  Injury  
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. This report is associated with mfr report numbers: 1. 3005168196-2016-00187, 2. 3005168196-2016-00188, 3. 3005168196-2016-00189. The hospital disposed of the device.
Event Description
On (b)(6) 2015, the patient received tpa and underwent a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace), a penumbra system 3max reperfusion catheter (3max), a penumbra system 5max separator (sep5) and a neuron max 6f 088 long sheath (neuron max). During the procedure, the patient suffered an intracranial hemorrhage and was anti-coagulated since the physician believed the patient's stroke was from hypercoagulability. In (b)(6) 2015, the patient had worsening of left-sided weakness and was found to have a right subdural hematoma (sdh), which was evacuated. The patient's warfarin was discontinued. On (b)(6) 2015, the patient returned with dizziness and worsened left sided weakness. In late (b)(6) 2015, the patient again had worsening of the left-sided weakness. A computed tomography (ct) of the patient's head was performed and revealed some right hemisphere edema. On (b)(6) 2015, a subsequent magnetic resonance imaging (mri) was performed, which showed marked increase in fluid-attenuated inversion recovery (flair) hyper-intensity in the right temporal, occipital and parietal lobes. On (b)(6) 2015, a follow-up brain mri was performed, which showed extensive scattered foci of contrast enhancement scattered throughout the right hemisphere and involving the leptomeninges of the right hemisphere. On (b)(6) 2016, the patient was admitted for a brain biopsy and was hospitalized with increasing headache and increasing weakness. On (b)(6) 2016, the brain biopsy was performed. The biopsy results showed necrotizing foreign body granulomatous inflammation secondary to endovascular polymer embolization. On (b)(6) 2016, the patient was taken to the operating room (or) for an open tumor biopsy in the right temporaperietal region. On (b)(6) 2016, the patient's biopsy results came in and revealed presence of areas of necrosis associated with a dense polymorphonuclear cell infiltrate surrounded by a histiocytic granulomatous reaction with presence of giant cells. In one of the granulomatous, filamentous granular pale blue foreign body material was identified consistent with fragments of catheter hydrophilic polymer coating. The inflammatory process appeared to involve the leptomeninges as well as the underlying brain parenchyma. Per the hospital staff's opinion, the presumed origin for the material would be the coating on the devices used for the patient's mechanical thrombectomy performed on (b)(6) 2015.
Event Description
Additional information provided by the customer: the thrombectomy procedure was a success and the patient did very well for a few months post treatment of the stroke. Another manufacturer's guidewire was also used for the procedure. Per the physician, it is unknown if the penumbra devices were contributory causes to the necrotizing foreign body in the patient and it is unknown what the cause of the necrotizing foreign body. As of (b)(6) 2016, the patient is doing better.
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Type of DeviceDQY
Manufacturer (Section D)
one penumbra place
alameda CA 94502
Manufacturer (Section G)
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda, CA 94502
MDR Report Key5445417
MDR Text Key38522454
Report Number3005168196-2016-00186
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberPNML6F088804
Device Lot NumberF61116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2016 Patient Sequence Number: 1