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

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	01/01/2014
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 access 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: 3005168196-2021-00847.3005168196-2021-00849.
Event or Problem Description
During its post-market surveillance activities on 25-mar-2021, penumbra inc.Became aware of a journal article titled, initial clinical experience using the two-stage aspiration technique (tsat) with proximal flow arrest by a balloon guiding catheter for acute ischemic stroke of the anterior circulation (matsumoto et al.2017).This article reports thirty-four consecutive patients who received treatment for acute ischemic stroke with penumbra system ace 60 reperfusion catheters (ace60s) and penumbra system 3max reperfusion catheters (3maxcs) between january 2014 and december 2015.It was reported that one extravasation occurred after use of the ace60, and two cases of post-procedural asymptomatic hemorrhagic infarction were observed after use of the ace60 together with the 3maxc.In one case it was noted that when the ace60 was advanced into the proximal m2 portion of the vasculature, it was extended on fluoroscopy.Immediately following angiography, extravasation of the m2 was visualized.The patient was treated with glue injection, resulting in m1 distal occlusion, but the clinical finding did not deteriorate.In two other cases using an ace60 and 3maxc together, post-procedural asymptomatic hemorrhagic infarctions were observed.However, no additional details regarding the direct cause of these events, nor the relationship to the ace60 and 3maxc, were specified.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11717875
• Report Number: 3005168196-2021-00848
• Device Sequence Number: 18629477
• Product Code: NRY
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021
• 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
• 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: 03/25/2021
• Initial Report FDA Received Date: 04/23/2021
• 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