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

Model Number	5MAXACE068
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	05/22/2021
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 left m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra balloon guide catheter, and a guidewire.During the procedure, the physician experienced resistance while advancing the ace68 through the balloon guide catheter and subsequently the physician bent the ace68 at approximately five centimeters from the hub.Therefore, the ace68 was removed.The procedure was completed using a new ace68 and the same balloon guide catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace68 revealed a proximal shaft fracture.This is likely the reported kink.If the device is forcefully advanced against resistance at an extreme angle during the procedure, damage such as a kink and subsequent fracture may occur.During functional testing, the ace68 was able to advance through a demonstration neuron max up to the fractured location without issue; therefore, the root cause of the reported 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 5MAX ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12208046
• Report Number: 3005168196-2021-01625
• Device Sequence Number: 3181357
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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): 07/29/2021
• 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: 05/19/2023
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F97937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005