MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Paralysis (1997)
Date of Event	11/15/2016
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.Potential adverse events with the use of the penumbra system 5max ace reperfusion catheter (5max ace) include hemorrhage and neurological deficits and are included in the labeling.Therefore, it was determined that the reported intracranial hemorrhage and aphasia were potential complications related to the use of the 5max ace.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
On (b)(6) 2016, the patient underwent a thrombectomy procedure to treat an acute-stage cerebral infarction using a penumbra system 5max ace reperfusion catheter (5maxace) and a non-penumbra stent retriever device.Fifteen hours after the procedure, a hemorrhagic transformation (ph2 level) occurred at the occlusion site.It is unknown whether or not additional treatment was performed after the original procedure, due to insufficient information.The intracranial bleeding was determined to have a probable relationship with the 5maxace.On (b)(6) 2016, the patient also suffered paralysis on the right side of the body and was confirmed to have aphasia.On (b)(6) 2016, the patient was transferred to another hospital.On (b)(6) 2016, the patient expired due to deteriorated general condition.The patient''s death was determined to be unrelated to the 5maxace.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7127738
• Report Number: 3005168196-2017-02237
• Device Sequence Number: 1080108
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 07/01/2019
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F70411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/18/2017
• 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
• Patient Age: 70 YR
• Patient Weight: 46