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

Model Number	PNS5F130SIM
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
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 femoral artery using a neuron select catheter 5f (5f select) and a non-penumbra short sheath.It was noted that the patient anatomy was calcified and tortuous.During the procedure, while advancing the 5f select through the short sheath, the physician kinked the distal end of the 5f select.The physician then decided to remove the 5f select.While retracting the 5f select with difficulty, the distal end of the 5f select broke off within the short sheath.The physician then attempted to retrieve the broken distal end of the 5f select using manual aspiration with a syringe but was unsuccessful.Therefore, the physician removed the short sheath containing the broken distal end of the 5f select.The procedure was completed using a new select and a new short sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed that catheter was fractured.It was indicated in the complaint that the distal end of the 5f select was kinked, while advancing during the procedure.If the 5f select is advanced against resistance, damage such as a kink may occur.This kink may have contributed to resistance upon subsequent retraction.The complaint reported retraction against resistance.If the device is forcefully retracted against resistance, the device may become fractured.Evaluation of the non-penumbra sheath revealed a kink on the sheath.The root cause of this damage could not be determined.If this was kinked during advancement of the 5f select during the procedure, it may have contributed to the resistance and subsequent kink experienced.Penumbra products 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.

• Brand Name: NEURON SELECT CATHETER 5F
• 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: 12850485
• Report Number: 3005168196-2021-02649
• Device Sequence Number: 4982392
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083125
• 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
• Report Date (Section B): 12/29/2021
• 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: 05/20/2024
• Device Model Number: PNS5F130SIM
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F106487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• 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: 10/24/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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 Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005