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

Catalog Number	PSR3D-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the psr3d was damaged on the proximal end of the stent portion.The psr3d was unable to be advanced through a demonstration 3maxc.Conclusions: evaluation of the returned psr3d revealed damage on the proximal end of the stent portion of the device.If the psr3d is forcefully advanced against resistance, the stent portion of the device may become damaged.During the functional test, the returned device was able to advance through the length of a demonstration 3maxc.However, additional resistance was experienced when advancing the device through the last 15 cm of the demonstration 3max.The damage on the returned psr3d likely contributed to the resistance experienced during functional testing.The root cause of the resistance experienced in the procedure could not be determined.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.This report is associated with mfr report number: 3005168196-2018-01913.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 3d revascularization device (psr3d).During the procedure, the psr3d was unable to advance through a penumbra system 3max reperfusion catheter (3maxc) after a couple of turns past the skull base.It was noted that the pushability in the psr3d was compromised; therefore, the psr3d and the 3maxc were removed and the procedure was completed using additional devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-01913.

• 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: 7920644
• Report Number: 3005168196-2018-01912
• Device Sequence Number: 16506271
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 08/29/2018
• 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: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: PSR3D-A
• Device Lot Number: F81384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 09/10/2019
• 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