MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 6F; DQY

Model Number	PNS6F125SIM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Death (1802); Edema (1820)
Date of Event	06/24/2019
Type of Reportable Event	Death
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 select catheter 6f, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated 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 number: 3005168196-2019-01448.
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 penumbra system jet 7 reperfusion catheter (jet7) and a neuron select catheter 6f (6f select).During the procedure, a mild catheter induced vasospasm was noticed in the m1 segment.The physician infused 5mg of verapamil into the right internal carotid artery (ica).The event was considered resolved as of (b)(6) 2019 with the infusion of verapamil.The vasospasm was adjudicated to be a non-serious adverse event with a definite relationship to the index procedure and a definite relationship to the jet7.On (b)(6) 2019, the patient had a second stroke in the cerebellum causing cerebral edema and was treated with decompressive occipital craniectomy.A computed tomography (ct) scan performed on (b)(6) 2019 showed a decrease in mass effect.The patient expired due to acute ischemic stroke on (b)(6) 2019.The acute ischemic stroke was adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.
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 penumbra system jet 7 reperfusion catheter (jet7) and a neuron select catheter 6f (6f select).During the procedure, a mild catheter induced vasospasm was noticed in the m1 segment.The physician infused 5mg of verapamil into the right internal carotid artery (ica).The event was considered resolved as of 24-jun-2019 with the infusion of verapamil.The vasospasm was adjudicated to be a non-serious adverse event with a definite relationship to the index procedure and a definite relationship to the jet7.On (b)(6) 2019, the patient had a second stroke in the cerebellum causing cerebral edema and was treated with decompressive occipital craniectomy.A computed tomography (ct) scan performed on (b)(6) 2019 showed a decrease in mass effect.The patient expired due to acute ischemic stroke on (b)(6) 2019.The acute ischemic stroke was adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.On 07-nov-2019, it was adjudicated that the acute ischemic stroke is unrelated to the 6f select.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra clinical team on 07 nov 2019: 1.Section b.Describe event or problem.Note: the acute ischemic stroke was previously adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.However, on 07-nov-2019, it was adjudicated that the acute ischemic stroke is unrelated to the 6f select.Therefore, this event is not considered reportable against the 6f select.This report is associated with mfr report number: 1.3005168196-2019-01448.H3 other text : placeholder.

• Brand Name: NEURON SELECT CATHETER 6F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8832710
• Report Number: 3005168196-2019-01447
• Device Sequence Number: 2070853
• Product Code: DQY
• UDI-Device Identifier: 00814548012070
• UDI-Public: 00814548012070
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022
• 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: 03/24/2022
• Device Model Number: PNS6F125SIM
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F89245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 06/26/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005