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

Model Number	PNML6F088804M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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.
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) and a non-penumbra short sheath.During the procedure, while attempting to insert a neuron max into a short sheath, the physician broke the distal tip of the neuron max.Therefore, the neuron max was removed.The procedure was completed using a new neuron max and the same short sheath.There was no report of an adverse effect to the patient.
Event or Problem Description
During preparation for a medical procedure, a hospital staff noticed that the distal tip of a neuron max 6f 088 long sheath (neuron max) was broken prior to insertion into a non-penumbra short sheath.The damage to the neuron max occurred prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max.
Additional Manufacturer Narrative
Please note that the following section is being corrected based on additional information provided by a penumbra sales representative on 03/02/2021: section b.Box 5.Describe event or problem.It was previously understood that the issue occurred while in use in the patient.However, based on the updated information, the issue occurred during preparation.Although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.

• 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: 11496945
• Report Number: 3005168196-2021-00506
• Device Sequence Number: 20147948
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: PNML6F088804M
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F77989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005