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

Catalog Number	PSR3D
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the pusher assembly of the penumbra system 3d revascularization device (psr3d) became bent on the back table while attempting to advance the psr3d.The damage to the psr3d was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new psr3d and a penumbra system ace 68 reperfusion catheter (ace68).
Additional Manufacturer Narrative
Results: the delivery wire had bends from approximately 135.0 ¿ 156.0 cm from the proximal end.The separator 3d was undamaged.Conclusions: evaluation of the returned psr3d confirmed bends on the delivery wire.If the device is forcefully mishandled during preparation for a procedure, damage such as bends may occur.During functional testing, the psr3d was able to be advanced through its introducer sheath without issue.Penumbra 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.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the follow-up #01 mfr report and are being corrected on this follow-up #02 mfr report: 3005168196-2019-00813.1.Section h.Box 6.Results code 1 h3 other text : placeholder.

• 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: 8556553
• Report Number: 3005168196-2019-00813
• Device Sequence Number: 2232209
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/27/2019
• 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: 06/26/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F84347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/21/2019; 01/14/2005
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/09/2019; 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