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

Catalog Number	PSR3D
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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 thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, a penumbra system ace 60 reperfusion catheter (ace60) was advanced together with a velocity delivery microcatheter and a guidewire into the target vessel.The velocity was then positioned distal to the thrombus and the psr3d was advanced through the velocity.As the physician was advancing the ace60 over the psr3d, he experienced resistance and reported that the ace60 was unable to advance up towards the psr3d.The physician then decided to remove the psr3d, and the device was no longer used in the procedure.The procedure was completed using the same ace60 and the same velocity.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
• MDR Report Key: 8601937
• Report Number: 3005168196-2019-00941
• Device Sequence Number: 2293826
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• 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
• Report Date (Section B): 04/12/2019
• 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: 06/07/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F83921
• Was Device Available for Evaluation?: No
• 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: 04/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005