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

Model Number	PNML6F088804M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional 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 product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a non-penumbra catheter and a stent retriever.During the procedure, the physician advanced a neuron max into the internal carotid artery without any issue, then advanced a catheter with a stent retriever into the target location.After a successful thrombectomy, an angiography was performed, the stent retriever and the catheter were retracted into the neuron max, and a detached markerband was noticed at the level of the m2 bifurcation of the left mca.Several attempts were made to remove the markerband using a non-penumbra device, then aspiration; however, the attempts were unsuccessful.Subsequently, several passes were made with combined use of an aspiration catheter and a stent retriever, and the markerband was successfully removed.A transient m2 vessel occlusion was successfully treated using tirofiban infusion.The final angiogram noted no angiographic sign of any remaining vessel occlusion.The procedure ended at this point.There was no report of an adverse effect to the patient.It was reported that the patient expired on (b)(6) 2021 after developing signs of a staphylococcus aureus bacteraemia (sab).

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11343382
• Report Number: 3005168196-2021-00299
• Device Sequence Number: 20041545
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: PNML6F088804M
• Device Catalogue Number: PNML6F088804M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005