MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number	PNS5F120BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Edema (1820)
Date of Event	04/16/2019
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 penumbra system include, 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: 3005168196-2019-01397.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy in the carotid terminus (carotid t) using a penumbra system 3d revascularization device (psr3d) and a neuron select catheter 5f (5f select).The patient¿s initial national institutes of health stroke scale (nihss) was a 11; however, the principle investigator (pi) noted that the nihss was at 20 later in the day.A stat computerized tomography (ct) shows no bleed but stroke in the right frontal and right parietal lobe consistent with ct perfusion and cerebral edema.This event is considered resolved with clinical sequelae as of (b)(6) 2019.These events were adjudicated to be serious adverse events with a possible relationship to the 5f select and psr3d, and a possible relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2019-01398.1.Section b.Box 5.Describe event or problem 2.Section d.Box 1.Brand name 3.Section d.Box 2.Product code 4.Section d.Box 2.Common device name 5.Section d.Box 4.Lot number/catalog number/expiration date/unique identifier 6.Section g.Box 5.Pma/510(k) # 7.Section h.Box 4.Device manufacture date this report is associated with mfr report number: 3005168196-2019-01397.
Event or Problem Description
On (b)(6)-2019, the patient underwent a thrombectomy in the carotid terminus (carotid t) using a penumbra system 3d revascularization device (psr3d) and a penumbra system jet7 reperfusion catheter (jet7).The patient¿s initial national institutes of health stroke scale (nihss) was a 11; however, the principle investigator (pi) noted that the nihss was at 20 later in the day.A stat computerized tomography (ct) shows no bleed but stroke in the right frontal and right parietal lobe consistent with ct perfusion and cerebral edema.This event is considered resolved with clinical sequelae as of (b)(6) 2019.These events were adjudicated to be serious adverse events with a possible relationship to the jet7 and psr3d, and a possible relationship to the index procedure.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8804917
• Report Number: 3005168196-2019-01398
• Device Sequence Number: 19625983
• Product Code: NRY
• UDI-Device Identifier: 00814548010182
• UDI-Public: 00814548010182
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 06/19/2019
• 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: 10/29/2021
• Device Model Number: PNS5F120BER
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F86693
• 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: 06/19/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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: Required Intervention
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005