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

Model Number	PNML6F088904M
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Thromboembolism (2654); Vascular Dissection (3160)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system ace 68 reperfusion catheter (ace68), and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician advanced a neuron max to the iliac artery.Subsequently, the physician experienced resistance while attempting to further advance the neuron max to the cervical artery.Therefore, the physician decided to remove the neuron max.Upon removal, it was noticed that the distal end of the neuron max was kinked.Afterwards, the physician injected contrast and noticed there was distal embolization and dissection in the iliac artery.The procedure was completed using a new neuron max, the same ace68, the same 3maxc.It was also reported that there is a possible relationship between the neuron max and the distal embolization and dissection.Later, two days post-procedure, the patient was seen at the hospital for observation and was discharged without any treatment for the distal embolization and dissection.
Additional Manufacturer Narrative
Potential adverse events in the labeling with the neuron max system include, but are not limited to, distal embolization, dissection, emboli, including death.Evaluation of the returned neuron max confirmed a kink in its distal shaft.If the device is forcefully manipulated against resistance, damage such as this may occur.Further evaluation of the device revealed that the distal shaft of the catheter lumen was damaged, the coils were exposed, and the device distal tip was ovalized.The root cause of this damage could not be determined.This damage was not identified in the reported complaint.This damage was likely incidental and may have occurred post-procedure prior to shipment back to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11745892
• Report Number: 3005168196-2021-00903
• Device Sequence Number: 4319003
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H10129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005