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

Catalog Number	PSR3D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
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 right m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).It should be noted that the patient's anatomy was very tortuous.After making one pass with the psr3d and a non-penumbra microcatheter, the technician removed the psr3d to clean out the clot and noticed that a tine on the proximal end of the psr3d had become broken.The psr3d was therefore no longer used in the procedure.The procedure was then completed using a non-penumbra device and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: bends were present from approximately 191.0 ¿ 198.5 cm from the proximal end.One leg of the penumbra system 3d revascularization device (psr3d) stent portion was fractured.Conclusions: evaluation of the returned psr3d confirmed a fracture on the proximal end of the psr3d stent portion.If the device is forcefully manipulated at extreme angles within a patient¿s tortuous anatomy or otherwise mishandled during the cleaning of the device after a pass, the stent portion may fracture.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.

• 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: 8722644
• Report Number: 3005168196-2019-01206
• Device Sequence Number: 11227540
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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): 05/23/2019
• 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: 12/26/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F87688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005