MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7KIT-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Weakness (2145); Stenosis (2263)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2019-01644.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the internal carotid artery (ica) supraclinoid using a penumbra system jet 7 reperfusion catheter (jet7) from a penumbra system jet 7 kit and a penumbra system 3d revascularization device (psr3d).During the procedure, it was reported that the first and second passes using the penumbra devices resulted in the patient's mtici flow becoming grade 1; additionally, and the third pass using the penumbra devices resulted in the patient's mtici flow becoming grade 2a.On (b)(6) 2019, the patient was discharged to a skilled nursing facility with a nihss score of 8.On (b)(6) 2019, the patient presented to the emergency department (ed) with left sided facial droop, cough, slurred speech, and left sided weakness.The computed tomography angiography scan (cta) showed high grade stenosis of the proximal m2 branch of the right middle cerebral artery (mca).The event was considered resolved as of (b)(6) 2019.The event was adjudicated to be a serious adverse event with a possible relationship to both the penumbra devices and the index procedure.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the clinical events committee on (b)(6) 2020: 1.Section b.Box 5.Describe event or problem this report is associated with mfr report number: 3005168196-2019-01644.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the internal carotid artery (ica) supraclinoid using a penumbra system jet 7 reperfusion catheter (jet7) from a penumbra system jet 7 kit and a penumbra system 3d revascularization device (psr3d).During the procedure, it was reported that the first and second passes using the penumbra devices resulted in the patient''s mtici flow becoming grade 1; additionally, and the third pass using the penumbra devices resulted in the patient''s mtici flow becoming grade 2a.On (b)(6) 2019, the patient was discharged to a skilled nursing facility with a nihss score of 8.On (b)(6) 2019, the patient presented to the emergency department (ed) with left sided facial droop, cough, slurred speech, and left sided weakness.The computed tomography angiography scan (cta) showed high grade stenosis of the proximal m2 branch of the right middle cerebral artery (mca).The event was considered resolved as of (b)(6) 2019.The event was adjudicated to be a serious adverse event with a possible relationship to both the penumbra devices and the index procedure.On (b)(6)2020, it was adjudicated that the event was not considered to be an adverse event and was unrelated to the jet7, the psr3d and the index procedure.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8947390
• Report Number: 3005168196-2019-01643
• Device Sequence Number: 11300586
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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,Followup
• Report Date (Section B): 07/30/2019
• 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: 10/24/2021
• Device Model Number: 5MAXJET7KIT-A
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F86649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005