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

Model Number PNML6F088904-R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00986.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician completed a pass using a jetd and a neuron max.Upon attempting to remove the jetd, the physician noticed that the jetd was stuck inside the neuron max.Therefore, the physician removed the jetd and neuron max together.Afterwards on the back table, the physician attempted to remove the jetd from the neuron max forcefully but was unsuccessful.Consequently, the jetd became stretched during the attempt to remove it from the neuron max.The procedure was completed using a new jetd and a new neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned jetd confirmed that the catheter was stretched.Further evaluation revealed that the catheter was fractured.If the jetd is forcefully retracted against resistance, damage such as stretching and a subsequent fracture may occur.This damage likely occurred during the forceful attempt to remove the jetd from the neuron max outside of the patient as mentioned in the complaint.Evaluation of the returned neuron max revealed that the catheter was kinked and ovalized.The root cause of the kink and ovalization could not be determined; however, this damage likely contributed to the resistance encountered during the removal of the jetd from the neuron max.During the functional test, a stainless-steel mandrel was unable to be advance through the hub and distal end of the neuron max due to blockage inside the lumen.Penumbra devices are visually 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.This report is associated with mfr report number: 3005168196-2021-00986.H3 other text : placeholder.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:.1.Section g.Box 3.Report source.This report is associated with mfr report number: 3005168196-2021-00986 h3 other text : placeholder.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: 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: 11795377
• MDR Text Key: 249715093
• Report Number: 3005168196-2021-00987
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: PNML6F088904-R
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male