MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Model Number	PSC054-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/17/2018
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 product lot number was not provided; therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2020-01325, 3005168196-2020-01326, 3005168196-2020-01327, 3005168196-2020-01329, and 3005168196-2020-01330.
Event or Problem Description
Penumbra inc.Became aware on 2019-04-15 during its post-market surveillance activities, of a neuroradiology journal titled, "thrombectomy for acute ischemic stroke in the elderly: a ''real world'' experience." (alawieh et al.2018).It was reported that 336 patients underwent thrombectomy procedure using penumbra system ace 60 reperfusion catheter (ace60), penumbra system ace 64 reperfusion catheter (ace64), penumbra system ace 68 reperfusion catheter (ace68), penumbra system 5max reperfusion catheter (5maxc), penumbra system 4max reperfusion catheter (4maxc) and penumbra system 3max reperfusion catheter (3maxc).All data were collected from a tertiary center between january 2013 and november 2017.Among all patients, adverse events included: hemorrhages and deaths.There is no allegation within the article that a malfunction of the penumbra system occurred.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all adverse events within this literature source.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10468504
• Report Number: 3005168196-2020-01328
• Device Sequence Number: 16894381
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019
• 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 Model Number: PSC054-B
• Device Catalogue Number: PSC054
• 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: 04/15/2019
• Initial Report FDA Received Date: 08/28/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005