MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Model Number	PSR3D-C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned psr3d revealed that the pusher wire was kinked, and the psr3d stent was damaged.This damage was likely due to forceful advancement against resistance.The fracture in the velocity likely contributed to resistance during advancement.Penumbra catheters and revascularization devices 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.This report is associated with mfr report number: 3005168196-2021-02646.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), a penumbra system 3d revascularization device (psr3d) and a penumbra system red 62 reperfusion catheter (red62).During the procedure, while attempting to advance the psr3d through the velocity and the red62, the physician noticed under fluoroscopy that the velocity was broken into two pieces approximately 10 inches from the hub.The psr3d was then removed and resheathed.The physician then pulled the proximal end of the velocity out and removed the distal end by clamping down on the velocity at the groin and subsequently by pulling it out along with the red62.It was also reported that there was no physical damage noted on the psr3d.The procedure was completed using a new velocity, a new red62 and a new psr3d.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• 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: 12849438
• Report Number: 3005168196-2021-02647
• Device Sequence Number: 11898880
• Product Code: NRY
• UDI-Device Identifier: 00815948020900
• UDI-Public: 00815948020900
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021
• 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: 12/01/2023
• Device Model Number: PSR3D-C
• Device Catalogue Number: PSR3D
• Device Lot Number: F102392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• 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: 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005