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

Model Number	PSR3D
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the delivery wire was kinked approximately 158.0 cm from the proximal end.Unknown substance was observed inside its delivery sheath.Conclusions: evaluation of the returned psr3d confirmed that the device was unable to be advanced out of its delivery sheath.Further evaluation of the device revealed unknown substance was inside the delivery sheath.This unknown substance likely contributed to the reported device unable to be advanced out of its sheath during the procedure.During functional testing, the returned psr3d was unable to be advanced or retracted from its delivery sheath and the unknown substance was not be able to flush out of the sheath with the solution.The functional test could not be continued.The root cause of these unknown substance could not be determined.Further evaluation of the device also revealed a delivery wire kink.This damage was likely a result of forceful advancement against resistance during the procedure.Penumbra separators 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 in the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d) and microcatheter.During the procedure, the psr3d would not advance out of its sheath and into the hub of the microcatheter.Therefore, the psr3d was removed.The procedure was completed using a non-penumbra stent retriever.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: 11027322
• Report Number: 3005168196-2020-02293
• Device Sequence Number: 668536
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• PMA/510(K) Number: K162901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020
• 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: 07/10/2022
• Device Model Number: PSR3D
• Device Catalogue Number: PSR3D
• Device Lot Number: F91667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/17/2020
• 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