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

Catalog Number	PNML6F088904
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number:.3005168196-2022-00242.
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 red 72 reperfusion catheter (red72), a velocity delivery microcatheter (velocity), a non-penumbra stent retriever, a penumbra select catheter, a non-penumbra sheath, and two guidewires.It was reported that there was a small dissection in the internal carotid artery (ica) prior to the procedure.During the procedure, the physician obtained access in the femoral artery using the 8f sheath.Then, the physician advanced the neuron max into the left internal carotid artery (ica) using the select catheter and guidewire.Next, the physician advanced the red72 over the velocity, and guidewire through the neuron max to the clot in the target vessel.Next, the physician removed the guidewire and advanced the stent retriever device through the velocity and into the target vessel.After removing the velocity, the physician initiated aspiration and successfully completed one pass using the red72 and stent retriever device.Subsequently, the physician removed the red72 and stent retriever device.The physician then completed another pass using the same steps.After the second pass, while retracting the red72 and stent retriever device through the neuron max, the physician experienced resistance.Therefore, the physician decided to remove the neuron max as well.Upon removal of the devices, the physician noticed the red72 to be unraveled in two areas at the distal end and the neuron max to be ovalized at the distal end.Therefore, the neuron max was not used for the remainder of the procedure.The physician then inserted a new neuron max to take the final pictures.The size of the dissection in the ica was noted to be larger than the size at the beginning of the procedure.The procedure was completed after the final pictures were taken.The use of the red72 and neuron max may have contributed to the worsening of the pre-existing dissection in the ica.It should be noted that no action was taken to treat the dissection of the ica.
Additional Manufacturer Narrative
Vessel perforation is included as a possible complication in the instructions for use (ifu) for the penumbra system.Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2022-00242.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14527252
• Report Number: 3005168196-2022-00241
• Device Sequence Number: 15000266
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 815948022393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022
• 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: 01/30/2025
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H12473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005