MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

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

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the venous sinus using a penumbra system 3max reperfusion catheter (3maxc), a non-penumbra guide catheter, and a guidewire.During the procedure, the physician completed one pass with the 3maxc.Next, while advancing the 3maxc to take measurements, the physician met resistance.Subsequently, the 3maxc fractured at the proximal location.Therefore, the 3maxc was removed.When examining on the back table, the 3maxc separated completely at the fractured location.The procedure was completed using a new 3maxc.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Please note the following section was updated: 1.Section b.Box 5.Describe event or problem evaluation of the returned 3maxc revealed a fracture on the proximal shaft.Based on the reported event, it is likely that the kink worsened to a fracture during handling after removal from the patient.If the device is advanced against resistance, damage such as a kink may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed an ovalization proximal to the fracture.If the device is pinched or gripped during advancement, damage such as an ovalization may occur.Further evaluation also revealed multiple kinks along the catheter shaft.This damage was incidental to the complaint and may have occurred during packaging for return to penumbra.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.Note: evaluation of the returned 3maxc revealed a fracture on the proximal shaft.Based on the reported event, it is likely that the kink worsened to a fracture during handling after removal from the patient.Since the kink likely worsened to a fracture during handling after removal from the patient, this information does not reasonably suggest that if this malfunction were to recur, it could cause or contribute to a serious injury or death.Therefore, this event is not considered reportable against the 3maxc.H3 other text: placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the venous sinus using a penumbra system 3max reperfusion catheter (3maxc), a non-penumbra guide catheter, and a guidewire.During the procedure, the physician completed one pass with the 3maxc.Next, while advancing the 3maxc to take measurements, the physician met resistance and kinked the 3maxc.Therefore, the physician decided to remove the 3maxc.While examining on the back table, the 3maxc fractured at the kinked location.The procedure was completed using a new 3maxc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3MAX 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: 18466456
• MDR Text Key: 332985978
• Report Number: 3005168196-2024-00011
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160449
• 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: 01/01/2005,01/31/2024

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: 3MAXC
• Device Lot Number: F00007266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• 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: 12/15/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Female