MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 6F; DQY

Catalog Number	PNS6F125BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using a neuron select catheter 6f (6f select), a non-penumbra sheath, and a guidewire.During the procedure, the physician used the 6f select to deliver the guidewire to the target location to prepare for cannulation.While removing the 6f select from the patient, the physician visualized under fluoroscopy that the distal end of the 6f select had fractured into two pieces.The physician attempted to remove the fractured piece of the 6f select using a snare and a catheter and fractured it again.Approximately three centimeters of the distal end piece of the 6f select was able to be removed from the patient and the last piece of the 6f select remained in a small branch of the right pulmonary artery.The physician decided to leave the remaining piece of the 6f select in the patient as it was deemed that it would not harm the patient.The procedure was completed using an indigo system aspiration catheter 8 (cat8), the same sheath, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 6f select confirmed that the distal end of the catheter was fractured.This damage typically occurs if the device is manipulated or torqued against resistance.Further evaluation revealed a fracture and kink on the distal fractured segment.This damage was reported to have occurred while snaring the distal fractured segment.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.

• Brand Name: NEURON SELECT CATHETER 6F
• 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: 17674380
• Report Number: 3005168196-2023-00416
• Device Sequence Number: 6116709
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 814548012094
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 09/27/2023
• 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: 10/15/2023
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F101140
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005