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

Catalog Number 5MAXACE068KIT

Device Problems Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 02/07/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure to treat an acute cerebral infarction using a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the physician was experiencing resistance advancing the ace68 up to the clot and, consequently, the ace68 became stretched.Therefore, it was removed.The procedure was completed using a new ace68.It is unknown if there was any adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ace68 confirmed that the device was stretched and ovalized on its distal shaft.This damage is typically a result of forcefully retracting the device against resistance.The root cause of the resistance could not be determined.During functional testing, the ace68 was unable to advance into a demonstration neuron max due to the distal shaft ovalization.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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11438875
• MDR Text Key: 239232190
• Report Number: 3005168196-2021-00441
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5MAXACE068KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• 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: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR