MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Catalog Number	PSC054
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility on a mandatory and voluntary report form with the following reference number: (b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2018-02316.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system 5max reperfusion catheter (5maxc) and a velocity delivery microcatheter (velocity).During the procedure, the physician gained access to the thrombus through the left carotid artery.However, the physician then was unable to withdraw the 5maxc and noticed that the velocity and guidewire were stuck.After multiple attempts, the physician was able to remove the guidewire and found that it had broken off within the catheter, leaving a portion of the guidewire within the catheter.The physician then saw through imaging that the aspiration catheter had become kinked at the opening of the sheath and, therefore, was unable to be retracted.Therefore the physician did a carotid cutdown to remove the sheath with the damaged catheter and wire inside.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8100119
• Report Number: 3005168196-2018-02317
• Device Sequence Number: 11063573
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PSC054
• Device Lot Number: F65574
• Was Device Available for Evaluation?: No
• 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: 10/26/2018
• Initial Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005