MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Model Number PNS5F130SIM

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 05/03/2021

Event Type  malfunction  

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 number: 3005168196-2021-01237.

Event Description

The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a neuron select catheter 5f (5f select), a neuron max 6f 088 long sheath (neuron max), a non-penumbra short sheath and a non-penumbra long sheath.During the procedure, while advancing a 5f select halfway through a short sheath, the 5f select became stuck and would not advance further.Therefore, the 5f select and the short sheath were removed.Next, while advancing a neuron max halfway through a long sheath, the physician experienced resistance.Subsequently, the neuron max became stuck and would not advance further.Therefore, the neuron max was removed.Afterwards, the physician performed another diagnostic test and decided that the patient did not need intervention.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: NEURON SELECT CATHETER 5F
• 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: 11932550
• MDR Text Key: 254295390
• Report Number: 3005168196-2021-01236
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K083125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2024
• Device Model Number: PNS5F130SIM
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F103826
• Was Device Available for Evaluation?: No
• 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: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: 72 YR
• Patient Weight: 67