MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Model Number	4MAXCKIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-02424.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m3 segment of the middle cerebral artery (mca) using a penumbra system 4max reperfusion catheter (4maxc) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician made a couple of attempts to insert the 4maxc into the neuron max; however, resistance was encountered at the proximal portion of the 4maxc and, therefore, it was removed.The physician then attempted to insert a new 4maxc into the neuron max; however, the same resistance issue occurred and, therefore, the 4maxc was removed.The procedure was completed using a new 4maxc and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the second 4maxc was kinked at approximately 95.0 cm from the hub.The device was ovalized at approximately 96.0 cm thru 107.0 cm from the hub.Conclusions: evaluation of the returned first 4maxc revealed an ovalization and kinks on its catheter shaft.If the 4maxc is mishandled during the procedure, damage such as an ovalization may occur.The ovalization on the 4maxc likely contributed to the reported resistance during the advancement of the device through the neuron max.Forceful advancement of the device against resistance may contribute to the catheter kinks which were observed near the ovalization on the catheter.During functional testing, the returned 4maxc was unable to be advanced through the returned neuron max and a demonstration neuron max due to the catheter ovalization.Evaluation of the returned second 4maxc revealed an ovalization and a kink on its catheter shaft.If the 4maxc is mishandled during the procedure, damage such as an ovalization may occur.The ovalization on the 4maxc likely contributed to the reported resistance during the advancement of the device through the neuron max.Forceful advancement of the device against resistance may contribute to the catheter kink which was observed near the ovalization on the catheter.During functional testing, the returned 4maxc was unable to be advanced through the returned neuron max and a demonstration neuron max due to the catheter ovalization.Evaluation of the returned neuron max revealed an undamaged and a functional device.During functional testing, a demonstration 4maxc was able to be advanced through the neuron max without issue.The neuron max was used in the procedure and no allegation was against this device.Penumbra catheters 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.This report is associated with mfr report number: 3005168196-2019-02424.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9526245
• Report Number: 3005168196-2019-02425
• Device Sequence Number: 16722713
• Product Code: NRY
• UDI-Device Identifier: 00814548016740
• UDI-Public: 00814548016740
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K160449
• 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,Followup
• Report Date (Section B): 12/06/2019
• 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: 05/20/2021
• Device Model Number: 4MAXCKIT
• Device Catalogue Number: 4MAXCKIT
• Device Lot Number: F83554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005