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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
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 thrombectomy procedure in the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f (6f select), penumbra system red 62 reperfusion catheter (red62), a non-penumbra short sheath, and a guidewire.During the procedure, the physician placed the short sheath and the neuron max in the patient.While attempting to advance the 6f select through the neuron max, the physician experienced resistance and was unable to advance the 6f select further.While attempting to retract the 6f select, the physician experienced resistance again and the 6f select became stuck within the neuron max.Therefore, the 6f select and neuron max were removed together.Upon removal, the physician noticed that the distal end of the neuron max was fractured.Therefore, the physician used the red62 to aspirate the distal end segment of the neuron max.The procedure was completed using a new neuron max, a new 6f select and the same penumbra system red 62 reperfusion catheter (red62).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max confirmed that the distal tip was fractured.The distal tip of the catheter may become damaged if the neuron max is advanced against resistance.Based on the reported event, the distal tip damage on the neuron max may have caused resistance and prevented the 6f select from advancing through the neuron max.Retracting the 6f select against resistance within the neuron max may have worsened the distal tip damage to the observed fracture.The root cause of the initial resistance during the procedure could not be determined.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 2 mfr report: 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: 18347957
• Report Number: 3005168196-2023-00555
• Device Sequence Number: 5341472
• Product Code: DQY
• UDI-Device Identifier: 00815948022409
• UDI-Public: 00815948022409
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024
• 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 Expiration Date: 07/24/2026
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H00003287
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/14/2005
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/04/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005