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

Catalog Number	PNML6F088904M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	08/20/2019
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 in the labeling with the neuron max system include, but are not limited to, vessel spasm, thrombosis, dissection, or perforation, hematoma or hemorrhage at puncture site, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).After the procedure, the control angiogram imaging indicated that a vasospasm had occurred.The patient was subsequently treated with a vasodilator (nimodipine) and heparin.Following treatment with the intravenous fluids, the patient's condition improved and resolved on the same day.The patient was discharged to another hospital on (b)(6) 2019.The vasospasm was adjudicated to be a serious adverse event with a definite relationship to the neuron max and index procedure.

• 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: 9192662
• Report Number: 3005168196-2019-01941
• Device Sequence Number: 1879219
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2022
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F89286
• 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: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• 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: 60 YR
• Date Report Sent to FDA: 01/01/2005