MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Model Number	5MAXACE132-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a non-penumbra microcatheter and a guidewire.It was noted that the patient anatomy was tortuous.During the procedure, while advancing an ace60 with a microcatheter over a guidewire, the ace60 would not advance past the ophthalmic artery; therefore, it was removed.Upon removal, it was noticed that the ace60 had a crease mark approximately 50 mm from the distal tip.The procedure was completed using another ace60, the same microcatheter and guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: a slight kink was present approximately 128.5 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed a slight kink on the distal shaft.This type of damage typically occurs if the device is advanced against resistance.During functional testing, the ace60 was advanced through a demonstration neuron max without an issue and a demonstration 3maxc was advanced through the ace60 without an issue.No other devices associate with the complaint were returned for evaluation; therefore, the root cause of the resistance experienced during the procedure could not be determined.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.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9458054
• Report Number: 3005168196-2019-02312
• Device Sequence Number: 3077912
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019
• 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: 05/16/2021
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F83491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005