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

Catalog Number 5MAXACE068KIT

Device Problem Fracture (1260)

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

Event Date 11/16/2022

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 middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a penumbra system 3max reperfusion catheter (3maxc), and a non-penumbra guide catheter.During the procedure, while attempting to make the first pass, the physician was unable to advance the ace68 over the 3maxc.Therefore, the physician removed the 3maxc and ace68 together, and noticed the distal end of the ace68 was fractured and was held together by a wire.Therefore, the ace68 was not used for the remainder of the procedure.It was also reported that the physician decided to use a new 3maxc, there was no noticeable damage to the 3maxc.The procedure was completed using a new ace68 and a new 3maxc.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ace68 confirmed a fracture on its distal shaft.If the ace68 is manipulated against resistance during use, damage such as a fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16091748
• MDR Text Key: 308543616
• Report Number: 3005168196-2022-00616
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 815948022850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: H00000559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1