MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number PNML6F088804

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Paralysis (1997); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Results: the neuron max 6f 088 long sheath (neuron max) distal tip showed signs of compression and buckling, suggesting that the tip may have folded over itself during use.The distal tip of the braided shaft was ovalized and deformed, and the markerband was missing.The neuron max distal tip was cut longitudinally by the penumbra investigator to allow for further evaluation.An imprint of where the marker band was previously laminated to the neuron max showed that the markerband was slightly overhanging at this location.Conclusions: evaluation of the returned device revealed signs of distal tip buckling and compression that are consistent with the tip folding over itself during use.In addition, the distal end of the braided shaft showed signs of ovalization.During insertion into the patient, it is likely that the neuron max tip became weakened and compressed against the patient's anatomy.In addition, because the neuron max has a hydrophilic coating at the distal tip, it is likely that the neuron max was gripped firmly to overcome the device lubricity during the insertion into patient anatomy in such a way that could have caused ovalization on the distal end of the braided shaft at the location of the markerband.The ovalization, buckling, and compression observed on the distal tip likely contributed to the separation of the markerband from the neuron max tip.Further evaluation revealed a small portion of the markerband imprint was distal to the distal braid.Examination of devices from previous cases with similar failure modes revealed that the small amount of markerband overhang observed in this case was an incidental finding and not a root cause for this complaint.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 medical procedure in the right internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).It was noted that the patient had no tortuosity or compromised arteries.During the procedure, the physician advanced the neuron max pass the internal and external carotid bifurcation and then advanced the tip of the neuron max into the right common carotid artery (cca) without any resistance.The physician then noticed that the marker band of the neuron max was detached and caught at the bifurcation.After removing the diagnostic catheter, the physician pressed on the fluoroscopy and noticed that the marker band had migrated up to the middle cerebral artery (mca).The physician then attempted to retrieve the marker band through aspiration using a penumbra system ace 68 reperfusion catheter (ace68), two non-penumbra catheters and non-penumbra stent retrievers but ended up perforating the right mca with the stent retriever.Therefore, the procedure was aborted and the marker band was left in the mca.The patient was extubated but could not move her left side.As of (b)(6) 2018, the patient is still in the intensive care unit (icu).

Event Description

Upon review of the complaint file, it was identified that additional information regarding the patient¿s health status and medical intervention performed were provided on a user facility report.Penumbra is supplementing its mdr with the following details from the user facility report: after the procedure, the patient was taken to the intensive care unit (icu) and intubated on a mechanical ventilator.Subsequently, a computed tomography (ct) revealed a herniation of the brain; therefore, an emergency right hemi-craniotomy was performed.At a later date (not provided), the patient was being weaned off the ventilator and was following simple commands with left hemiparesis.An additional brain ct scan at a later date (not provided) revealed a right frontal lobe intraparenchymal hemorrhage with adjacent subarachnoid hemorrhage and 2mm herniation.A brain ct scan revealed an acute right sided middle cerebral artery infarct and stable right intraparenchymal hematoma and right middle cerebral artery infarct with decrease midline shift.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7238221
• MDR Text Key: 98909787
• Report Number: 3005168196-2018-00243
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/07/2018
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F66825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR