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

Catalog Number	PNS5F130BER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the returned device was fractured approximately 124.0 cm from the hub, at the distal catheter joint.The device also had a kink approximately 125.0 cm from the hub.Conclusions: evaluation of the returned 5f select revealed a fractured device.If the catheter is forcefully retracted or torqued against resistance, damage such as a fracture may occur.Further evaluation revealed a kink on the distal fractured length of the device.If the distal segment of the device became pinned, this kink damage may occur, and it may contribute to resistance when retracting the device.The vascular retrievers may have also contributed to the kink damage.The non-penumbra sheath 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 medical procedure in the left internal carotid artery (ica) using a neuron select catheter 5f (5f select).During the procedure, the physician placed a non-penumbra sheath in the left ica over a 5f select and a non-penumbra guidewire without issue.The physician then removed the 5f select and upon fluoroscopy, it was noticed that the tip of the 5f select was still on the screen.At that point, the physician inspected the 5f select on the back table and noticed that the entire black tip was missing.After multiple passes with vascular retrievers, the broken 5f select tip was removed from the patient without incident.The procedure was successfully completed by placing a carotid stent.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a medical procedure in the left internal carotid artery (ica) using a neuron select catheter 5f (5f select).During the procedure, the physician placed a non-penumbra sheath in the left ica over a 5f select and a non-penumbra guidewire without issue, though there was slight resistance, and it was reported there was slight tortuosity in the vessel.The physician then removed the 5f select and upon fluoroscopy, it was noticed that the tip of the 5f select was still on the screen.At that point, the physician inspected the 5f select on the back table and noticed that the entire black tip was missing.After multiple passes with vascular retrievers, the broken 5f select tip was removed from the patient without incident.The procedure was successfully completed by placing a carotid stent.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: 8079518
• Report Number: 3005168196-2018-02271
• Device Sequence Number: 1780136
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2018
• 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: 06/22/2020
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F77868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/26/2018; 06/13/2019; 10/24/2019
• 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: 57 YR
• Date Report Sent to FDA: 01/01/2005