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

Catalog Number	PNML6F088904
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the right vertebral artery using a neuron max 6f 088 long sheath (neuron max), an 8f non-penumbra sheath, and a non-penumbra guiding catheter.It was reported that the patient¿s right vertebral artery was stenotic.During the procedure, the physician used the 8f sheath to puncture the patient¿s femoral artery and then advanced the neuron max.Once the neuron max reached the abdominal aorta, an angiography tube was inserted to guide the neuron max into the target vessel.While advancing the neuron max into the target vessel, the physician experienced resistance; and subsequently, the physician broke the neuron max towards the mid to distal end inside the patient.Therefore, the neuron max was removed.The procedure was completed using a new neuron max and the same 8f sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max confirmed a fracture on the mid-shaft.Yield marks were present near the fractured location.This indicated that the device was kinked prior to fracture.If the device is advanced against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation of the device revealed kinks throughout the catheter and an ovalization at the distal tip.Based on the returned condition, this damage was likely incidental to the complaint and may have occurred during packaging for the device return.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: 14458968
• Report Number: 3005168196-2022-00221
• Device Sequence Number: 4685469
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 814548012179
• 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): 08/17/2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2023
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10647
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005