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

Catalog Number	PNS5F130SIM
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
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 right middle cerebral artery (mca) using a neuron select catheter 5f (5f select), a non-penumbra sheath, and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the physician inserted the sheath into the iliac artery, then advanced the 5f select into the sheath.While advancing the 5f select through the distal end of the sheath, the physician experienced resistance and the distal end of the 5f select kinked due to tortuosity in the pelvis axis.After advancing the 5f select approximately four centimeters out of the distal end of the sheath in the iliac artery, the physician attempted to advance the guidewire through the 5f select; however, the guidewire would not advance out the distal end of the 5f select.It was then noticed that the guidewire had perforated the distal end of the 5f select and subsequently, the distal end of the 5f fractured at the kink location.Next, the physician made access through the opposite side of the groin and performed a successful intracranial thrombectomy of the right mca.Afterwards, the physician removed the fractured distal end of the 5f select using a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed a fracture on the distal shaft.The complaint stated that resistance was experienced during the procedure.If the 5f select is advanced against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported event, the patient''s tortuous anatomy may have contributed to some resistance experienced during the procedure.Further evaluation of the device revealed an additional kink distal to the fractured location.Based on the reported event, this damage was likely incidental to the complaint and likely occurred during snaring the device to remove from the patient.Penumbra catheters are 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.H3 other text: placeholder.

• 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: 16288067
• Report Number: 3005168196-2023-00060
• Device Sequence Number: 6475354
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 814548010236
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/02/2023
• 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: 08/17/2025
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: H00000935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/07/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005