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

Catalog Number	PSR3D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2019
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
The patient was undergoing a thrombectomy procedure in the a1 segment of the anterior cerebral artery (aca) using penumbra system 3d revascularization devices (psr3ds).During the procedure, the physician advanced a penumbra system 3max refusion catheter (3maxc) through a penumbra system jet 7 reperfusion catheter (jet7), then used a psr3d to engage the thrombus.While retracting the psr3d back into the 3maxc, the physician experienced resistance.After pulling very hard, the physician was able to pull the psr3d through the 3max and the jet7.While cleaning and preparing to reintroduce the psr3d for the second pass, the hospital technologist noticed the proximal strut connecting the psr3d to the pusher assembly was broken; therefore, the psr3d was not used for the remainder of the procedure.The procedure was then completed using another psr3d, the same 3maxc and jet7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the psr3d had bends from approximately 180.0 ¿ 184.0 and 195.0 cm from the proximal end.One leg of the psr3d stent portion was fractured.Conclusions: evaluation of the returned psr3d confirmed a fracture on the stent portion of the psr3d.If the device is forcefully retracted against resistance, damage such as a fracture may occur.The 3maxc and jet7 identified in the complaint were not returned for evaluation; therefore, the root cause of the reported resistance was unable to determined.Further evaluation revealed bends on the core wire.These damages were likely incidental to the reported complaint.Penumbra revascularization devices are inspected during in-process inspection and during quality inspection after manufacturing.Please note that two psr3ds were used in this procedure with lot numbers c16186 and c07670; however, it is unknown which psr3d had the fracture on the stent portion.Therefore, both lots were reviewed.1.Lot #: c16186, catalog #: psr3d, udi #: (b)(4), manufacture date: (b)(6) 2018, expiration date: (b)(6) 2024.2.Lot #: c07670, catalog #: psr3d, udi #: (b)(4), manufacture date: (b)(6) 2018, expiration date: (b)(6) 2021.The manufacturing records for the known lots above were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 8996858
• Report Number: 3005168196-2019-01727
• Device Sequence Number: 14169946
• 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,Followup
• Report Date (Section B): 08/13/2019
• 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: No Information
• Device Catalogue Number: PSR3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005