MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number RED72SDKIT

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 10/08/2023

Event Type  malfunction  

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number mw5147030: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a sendit delivery device (sendit), a neuron 6f 088 long sheath, and a microwire.During the procedure, the physician advanced the red72 with the sendit over the guidewire up to the ica and into the mca.The physician removed the sendit and performed one pass using the red72.After completion of the pass, a contrast run revealed small residual flow with narrowing in the mca.The physician then advanced the red72 and noticed that the red72 would not advance forward.While removing the red72, the physician experienced resistance and noticed that the red72 fractured at two locations near the distal part within the neuron max.The fractured pieces of the red72 were contained within the neuron max.A snare device was used to remove the fractured pieces of the red72 within the neuron max.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68), the same neuron max, and the same microwire.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed a fracture on the distal shaft.Evaluation revealed a kink distal to the fractured location.This indicates that the red72 may have become pinned during advancement.This likely contributed to the reported resistance experienced during retraction.If the red72 is retracted against resistance, the device may become stretched and subsequently fracture.Further evaluation of the device revealed an ovalization on the distal shaft.This damage was incidental to the complaint and the root cause of this 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.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 18070086
• MDR Text Key: 327730726
• Report Number: 3005168196-2023-00494
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 815948025943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/17/2023

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: RED72SDKIT
• Device Lot Number: F00008137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• 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: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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