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

Catalog Number	PSR3D
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product lot number was not provided, therefore, the manufacturing records could not be reviewed.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: 3005168196-2018-00517, 3005168196-2018-00541.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d) and a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient¿s anatomy was very tortuous.During the procedure, while attempting to track a psr3d through a 3maxc, the physician experienced resistance and subsequently, the psr3d would not advance and became bent; therefore, it was removed.The physician then attempted to advance a new psr3d through the 3maxc; however, the second psr3d would not track either.Therefore, the 3maxc and psr3d were removed and the procedure was ended at that point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-00517, 3005168196-2018-00541.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00517 and 3005168196-2018-00541.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00517 and 3005168196-2018-00541.

• 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: 7332444
• Report Number: 3005168196-2018-00518
• Device Sequence Number: 11164231
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2018
• 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 Catalogue Number: PSR3D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 11/28/2018; 09/09/2019; 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005