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

Model Number	5MAXACE068KIT-R
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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 right middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), neuron max 6f 088 long sheath (neuron max), and stent retriever.During the procedure, the physician completed the first pass using the ace68 and stent retriever.Subsequently, the physician experienced resistance removing the ace68 and stent retriever to perform a contrast run.The physician decided to perform another pass using the ace68; however, upon inspection of the ace68, the physician noticed the distal tip of the ace68 to be wrinkled and accordioned.Therefore, the ace68 was not used for the remainder of the procedure.The procedure was completed using another catheter with the same stent retriever and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace68 revealed that the distal tip had multiple consecutive kinks.This damage is likely the reported wrinkled and accordioned distal tip.If the device is forcefully manipulated against resistance, damage such as this may occur.During functional testing, the ace68 was advanced and retracted through a demonstration neuron max without an issue.The root cause of resistance 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.H3 other text: placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11353424
• Report Number: 3005168196-2021-00311
• Device Sequence Number: 16998185
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 00815948022850
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• 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): 01/25/2021
• 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: 06/19/2023
• Device Model Number: 5MAXACE068KIT-R
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: H10564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005