MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX SEPARATOR; NRY

Catalog Number	3MAXS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	03/15/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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: 3005168196-2016-00892, 3005168196-2016-00893, 3005168196-2016-00895.The hospital disposed of the device.
Event or Problem Description
On (b)(6) 2014, the patient successfully underwent a thrombectomy procedure using two penumbra system 3max reperfusion catheters (3max), a penumbra system 5max ace reperfusion catheter (5max ace) and a penumbra system 3max separator (sep3) without vascular injury.The patient remained intubated after the procedure and was transferred to the intensive care unit (icu) where broad-spectrum antibiotics were administered for sepsis for which the patient was being treated for prior to the procedure.The patient was on pressors to maintain adequate blood pressure.Later on that same day, the patient's hemoglobin was noted to be low and therefore, a blood transfusion was given.The physician reported this worsening anemia as a serious adverse event (sae) which was determined to be related to the penumbra system.Two days post-procedure, on (b)(6) 2014, the patient became hypotensive and unresponsive, requiring multiple pressors.The patient eventually had pulseless electrical activity (pea) and was resuscitated but continued to be bradycardic.The patient's family consented to a do not resuscitate (dnr) and subsequently, the patient expired on (b)(6) 2014.Pulseless electrical activity was reported as the cause of death and was not related to the penumbra system.Pea was reported as the cause of death and was not related to the penumbra system.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5749258
• Report Number: 3005168196-2016-00894
• Device Sequence Number: 880
• Product Code: NRY
• UDI-Device Identifier: 00814548012483
• UDI-Public: 00814548012483
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 3MAXS
• Device Lot Number: F35593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/24/2016
• 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: Other
• Patient Age: 76 YR