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

Model Number	PNML6F088904-R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2020
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.This report is associated with mfr report numbers: 3005168196-2020-02006, 3005168196-2020-02007.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).It was noted that the patient's anatomy was tortuous.During the procedure, the physician noticed the jet7 was leaking just beyond the hub while in use in the patient.Therefore, the jet7 was removed.Another jet7 was used to continue the procedure; however, the same issue occurred.It was also reported that while the neuron max was still inside the patient, the physician noticed that it was kinked; the neuron max was also removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and another neuron max.There was no report of an adverse effect to the patient.
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 #01 mfr report:3005168196-2020-02008 1.Section b.Box 5.Describe event or problem this report is associated with mfr report numbers: 1.3005168196-2020-02006 2.3005168196-2020-02007.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using penumbra system jet 7 reperfusion catheters (jet7)s and a neuron max 6f 088 long sheath (neuron max).It was noted that the patient's anatomy was tortuous.During the procedure, the physician noticed the jet7 was leaking just beyond the hub on the back table.Therefore, the jet7 was not used in the procedure.Another jet7 was used to continue the procedure; however, the same issue occurred.It was also reported that while the neuron max was still inside the patient, the physician noticed that it was kinked; the neuron max was also removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and another neuron max.There was no report of an adverse effect to the patient.

• 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: 10847303
• Report Number: 3005168196-2020-02008
• Device Sequence Number: 2419466
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2020
• 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: 05/12/2023
• Device Model Number: PNML6F088904-R
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10474
• 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: 10/18/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005