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 Codes	Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Date of Event	07/08/2012
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.Hemorrhage and perforation are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported subarachnoid hemorrhage and vessel perforation were anticipated procedural complications.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: 3005168196-2016-00539, 3005168196-2016-00540, 3005168196-2016-00542, 3005168196-2016-00543, 3005168196-2016-00544.The hospital disposed of the device.
Event or Problem Description
The patient underwent a thrombectomy procedure using a penumbra system 5max reperfusion catheter, a penumbra system 3max reperfusion catheter, a penumbra system 3max separator, a px slim delivery microcatheter, a neuron 6f select catheter and a neuron max 6f 088 long sheath.On post-operative day 1 and day 3, a non-contrast computerized tomography (ncct) was performed and revealed evidence of a subarachnoid hemorrhage (sah) in the dorsal insula and hemorrhagic transformation.The sah was noted to be due to vessel perforation.The patient showed overall clinical improvement in neurological status and was maintained on diltiazem and atenolol for atrial fibrillation throughout the hospital stay.On (b)(6) 2012, the patient was subsequently discharged to an acute rehabilitation nursing facility.The sah was reviewed and adjudicated by the committee to be a non-serious adverse event with a possible relationship to the penumbra system and angiographic procedure but unrelated to the index stoke.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5611970
• Report Number: 3005168196-2016-00541
• Device Sequence Number: 13561044
• Product Code: NRY
• UDI-Device Identifier: 00814548012483
• UDI-Public: 00814548012483
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2016

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: 10/31/2014
• Device Catalogue Number: 3MAXS
• Device Lot Number: F23448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/27/2016
• 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: Life Threatening; Other