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

Catalog Number PNML6F088904

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

Patient Problem Occlusion (1984)

Event Date 12/01/2015

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 neuron max system include, but are not limited to, hematoma or hemorrhage at the site, acute occlusion, 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.

Event Description

Penumbra inc.Became aware on (b)(6) 2020 during its post-market surveillance activities of a neurosurgery journal article titled, "transradial approach for complex anterior and posterior circulation interventions: technical nuances and feasibility of using current devices" (snelling, et al.2019).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.The patient in the first event underwent a thrombectomy procedure.Post-procedural testing following the use of a neuron max 6f 088 long sheath (neuron max) revealed a radial artery occlusion (rao), despite the use of anti-spasmolytics and patent hemostasis.However, no hand ischemia was seen.It was also reported that the patient eventually failed the transfemoral approach (tfa) due to significant aortic arch tortuosity when the physician attempted to cross over to this approach.It is unclear how this procedure was completed; however, there was no report of an adverse effect to the patient in this case.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10526276
• MDR Text Key: 206788817
• Report Number: 3005168196-2020-01475
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PNML6F088904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other