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

Model Number	PNS5F130SIM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a neuron select catheter 5f (5f select).During the procedure, while accessing the brachiocephalic artery, the 5f select fractured.Therefore, the physician used a goose neck snare to remove the broken piece of the 5f select.No additional information has been provided.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the sales representative on 01/14/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned 5f select confirmed a fracture on the distal shaft.If the device is forcefully manipulated against resistance at an extreme angle within patient anatomy, damage such as this may occur.Based on the lack of stretching near the fracture site, this catheter break was likely the result of a kink while trying to navigate the brachiocephalic artery.The additional fracture may have occurred during the snaring process and the distal fractured segment was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an aneurysm in the middle cerebral artery (mca) bifurcation using a neuron select catheter 5f (5f select) and neuron max 6f 088 long sheath (neuron max).During the procedure, while accessing the brachiocephalic artery using the 5f select and neuron max, the physician noticed the 5f select became fractured and, consequently, the distal tip of the 5f select broke off.Therefore, the physician used a goose neck snare to remove the broken piece of the 5f select.The procedure was completed using a neuron 6f 070 delivery catheter (neuron 070) and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11118184
• Report Number: 3005168196-2021-00006
• Device Sequence Number: 1059795
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: PNS5F130SIM
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F81957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005