MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE 68 REPERFUSION CATHETER; NRY

Model Number	5MAXACE068KIT
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
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 m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing approximately two centimeters of an ace68 through the distal tip of the neuron max, the ace68 became stuck.Therefore, the neuron max and the ace68 were removed together.Afterwards, it was noticed that the distal end of the ace68 was ovalized.The procedure was completed using a penumbra system 3max reperfusion catheter (3maxc), the same neuron max and a non-penumbra stent retriever.There was no report of an adverse effect to the patient.It was reported that after the procedure, the ace68 was flushed, and it was noticed that the ovalized area of the ace68 was kinked.
Additional Manufacturer Narrative
Evaluation of the returned ace68 revealed that the distal shaft was stretched.This damage is typically a result of forcefully retracting the device against resistance during use.The root cause of the resistance could not be determined.During functional testing, the ace68 was unable to be advanced through the returned neuron max due to the stretch in its distal shaft.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11905888
• Report Number: 3005168196-2021-01192
• Device Sequence Number: 19643766
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161640
• 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): 07/20/2021
• 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: 03/27/2023
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F97107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/30/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005