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

Model Number	5MAXACE068KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 internal carotid artery (ica), using a penumbra system (b)(4) reperfusion catheter ((b)(4)) and a non-penumbra guide catheter.During the procedure, the physician removed the (b)(4) and guide catheter for flushing.While re-advancing the (b)(4) approximately two-thirds of the way into the guide catheter on the back table, the physician encountered resistance.Therefore, the (b)(4) was no longer used in the procedure.The procedure was completed using a non-penumbra device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace68 revealed that the catheter was kinked and ovalized.If the ace68 is forcefully advanced against resistance, damage such as kinks and ovalization may occur.During decontamination lubricity was confirmed along the catheter shaft.The ace68 was then attempted to be advanced through the returned non-penumbra guide catheter; however, the ace68 could not be advanced through the returned non-penumbra guide catheter due to the ovalization in the guide catheter.The ace68 was advanced through a demonstration neuron max without an issue.Evaluation of the returned non-penumbra guide catheter revealed ovalization along the catheter shaft.This damage likely contributed to the resistance experienced during the procedure and prevented the returned ace68 from being advanced through the guide catheter during the procedure.Penumbra catheters are visually inspected during in-process 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 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11485498
• Report Number: 3005168196-2021-00496
• Device Sequence Number: 3804820
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161640
• 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): 02/14/2021
• 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: 06/27/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F91451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 52
• Date Report Sent to FDA: 01/01/2005