MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2013

Event Type  Injury  

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 puncture site, vessel spasm, thrombosis, dissection, or perforation, 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: 3005168196-2020-01143, 3005168196-2020-01144, and 3005168196-2020-01145.

Event Description

Penumbra inc.Became aware on 15-jul-2020 during its post-market surveillance activities of a neurosurgery journal article titled, ¿first attempt recanalization with adapt: rate, predictors, and outcome¿ (anadani et al., 2019).This article is a retrospective review of 524 patients with procedures taking place between 01-nov-2013 and 01-jan 2018 involving a neuron max 6f 088 long sheath (neuron max), a penumbra system ace 68 reperfusion catheter (ace68), a penumbra system ace 64 reperfusion catheter (ace64), and a penumbra system 3max reperfusion catheter (3maxc).The purpose of this study was to report the rate, predictors, and outcome of first-attempt recanalization (far) using the adapt technique.It was reported that 480 patients in this study experienced hemorrhagic complications.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 malfunctions and/or adverse events within this literature source.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: (b)(4).1.Section h.Box 10/11.Narrative/corrected data 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 neuron max system include, but are not limited to, hematoma or hemorrhage at puncture site, vessel spasm, thrombosis, dissection, or perforation, 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: 1.3005168196-2020-01143, 2.3005168196-2020-01144.3.3005168196-2020-01145 h3 other text : placeholder.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10381689
• MDR Text Key: 202197312
• Report Number: 3005168196-2020-01142
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other