MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX 3 REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Cerebral (1889)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2019, the patient successfully underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).There was no reported complication during the procedure.A 24-hour follow up magnetic resonance imaging (mri) scan was performed, which revealed minor asymptomatic hemorrhagic transformation on the left insula and operculum.The patient was discharged on (b)(6) 2019 in stable condition with a national institutes of health stroke scale (nihss) of 0.This event was considered unresolved.The asymptomatic hemorrhagic transformation on the left insula and operculum were adjudicated to be a non-serious adverse event with a possible relationship to the penumbra system and the index procedure.

• Brand Name: PENUMBRA SYSTEM MAX 3 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8701301
• Report Number: 3005168196-2019-01156
• Device Sequence Number: 2600603
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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
• Report Date (Section B): 05/16/2019
• 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: 02/25/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F88698
• 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: 05/16/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: Other
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005