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

Catalog Number	PSR3D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: one of the psr3d struts was fractured.Conclusions: evaluation of the returned psr3d revealed one of the two legs of the stent portion of the device was fractured.This damage was likely a result of forcefully retracting the device against resistance.If the psr3d is retracted into a microcatheter after capturing thrombus, resistance will likely be experience and damage may result.As reported, it may also have been a result of the cleaning process after the first successful pass.Penumbra system 3d 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 3d revascularization device (psr3d).It was noted that the patient had a severe middle cerebral artery (mca) stenosis.During the procedure, the physician placed a penumbra system ace60 reperfusion catheter (ace60), the advanced a velocity delivery microcatheter (velocity) through the ace60.After that, the physician advanced a psr3d through the velocity.While attempting to re-sheath the psr3d after the first pass, the scrub technologist noticed that one of the two points of connection to the psr3d pusher¿s assembly was broke.It is unknown if the psr3d was broken upon removal or if the damage occurred during cleaning.Therefore, the physician opened a new psr3d and advanced it into the target vessel; however, reperfusion was not achieved.After two unsuccessful attempts, the physician decided to remove the psr3d.There was no reported issue with the psr3d.The procedure was completed using the same ace60, velocity, another stent retriever device and angioplasty.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: 7419761
• Report Number: 3005168196-2018-00747
• Device Sequence Number: 18841943
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 03/16/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: PSR3D
• Device Lot Number: F79782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005