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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a right cerebral hemisphere occlusion using a neuron max 6f 088 long sheath (neuron max) and a penumbra system ace 60 reperfusion catheter (ace60).It should be noted that the patient had a type iii arch, and the right internal carotid artery (ica) c1 segment was stenosed and notably tortuous.During the procedure, the physician experienced resistance while advancing the ace60 and advanced the neuron max past the stenosis in the c1 segment to provide more support to the ace60.Subsequently, the physician visualized fluid leaking during continuous rotation of the proximal end of the neuron max.The physician then decided to remove the neuron max.After removing the neuron max from the patient, the physician cut the yellow coating of the neuron max and found that the neuron max was fractured at the proximal end near the hub and was causing fluid leakage.Therefore, the neuron max was removed.The procedure was completed using a new neuron max, the same ace60, a non-penumbra catheter to navigate beyond the c1 segment, and a guidewire to navigate beyond the stenosed c1 segment.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned neuron max confirmed that the catheter was fractured near the hub.The complaint indicated that a leak was observed during continuous rotation of the proximal end of the neuron max.If the neuron max is rotated against resistance during use, damage such as a fracture may occur.This fracture likely contributed to the reported leak.Further evaluation revealed that the braided shaft was exposed at the fractured location.This damage was incidental to reported complaint and likely occurred during handling of the device after it was fractured.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.

• 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: 19735503
• Report Number: 3005168196-2024-00247
• Device Sequence Number: 20612357
• Product Code: DQY
• UDI-Device Identifier: 00815948022409
• UDI-Public: 00815948022409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H00003918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005