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

Catalog Number 3MAXCKIT

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

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

Event Date 01/24/2023

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 m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra engine (engine), a non-penumbra catheter, a non-penumbra sheath, and a guidewire.It should be noted that the patient''s anatomy was tortuous and had arteriosclerosis.During the procedure, the physician completed a direct aspiration first pass (adapt) using the 3maxc and partial recanalization of the target vessel was achieved.When the 3maxc passed through the lesion a second time, resistance was encountered.It was also reported that there was no reverse flow after aspirating the thrombus.While retracting the 3maxc and catheter into the sheath under negative pressure, resistance was encountered.Upon removal, the 3maxc was found fractured and the distal end of the 3maxc remained in the m1 to the internal carotid artery (ica).Next, a snare device was used to retrieve the fractured piece of the 3maxc.On the back table, the physician noted that the distal end of the 3maxc was kinked near the fracture and was likely caused by the snare device.At this point, the procedure was ended.It was also noted that the target vessel was not fully recanalized; however, the patient was followed-up with on a later date.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned 3maxc confirmed that the catheter was fractured and revealed stretching near the fractured location.The complaint stated that resistance was experienced during the procedure.If the 3maxc is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported event, the patient's tortuous anatomy may have contributed to some resistance experienced during the procedure.Further evaluation revealed an ovalization on the distal fractured segment.This damage was incidental to the reported complaint and occurred while snaring of the device.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 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: 16444262
• MDR Text Key: 310270466
• Report Number: 3005168196-2023-00088
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/21/2023

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: 3MAXCKIT
• Device Lot Number: F109407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• 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: 02/02/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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