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

Model Number 5MAXACE068

Device Problems Suction Problem (2170); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

Event Type  malfunction  

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 Description

The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra sheath, a penumbra engine (engine), and a guidewire.During the procedure, the physician advanced the ace68 into the target vessel, connected the ace68 to the engine and initiated aspiration.The physician then noticed that the aspiration was low and decided to retract the ace68.After retracting the ace68, the physician noticed the distal end of the ace68 was ovalized.Therefore, the ace68 was not used for the remainder of the procedure.The procedure was completed using a new penumbra system ace reperfusion catheter and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ace68 confirmed a distal shaft ovalization.If the device is forcefully mishandled during advancement, damage such as a distal shaft ovalization may occur.This ovalization likely contributed to the reported low aspiration experienced during the procedure.During functional testing, the ace68 was able to advance through a demonstration neuron max without an issue.Water was aspirated through the ace68, and low flow rate was observed.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 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12351433
• MDR Text Key: 267627529
• Report Number: 3005168196-2021-01866
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F100532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR