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

Catalog Number 3MAXC

Device Problems Fracture (1260); Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 03/10/2023

Event Type  malfunction  

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 penumbra system 3max reperfusion catheter (3maxc), a benchmark bmx96 access system (benchmark max), and a guidewire.During the procedure, the 3maxc was advanced over the guidewire to the target location.Subsequently, the physician made several attempts to advance the red72 over the 3maxc to the target location, without success.While removing the red72 and 3maxc together, the physician experienced resistance and applied force to remove the devices.Upon removal, the physician observed that the proximal end of the red72 was stretched and the 3maxc was fractured at the distal end.Therefore, the red72 and the 3maxc were no longer used in the procedure.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68), the same benchmark max, a non-penumbra microcatheter, and a stent retriever to perform a combined technique of aspiration and clot retrieval using the stent retriever.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Manufacturer Narrative

Evaluation of the returned 3maxc confirmed that the catheter was fractured and revealed yield marks near the fractured location.If the 3maxc is retracted against resistance, damage such as a fracture may occur.Further evaluation revealed additional yield marks on the catheter shaft.This damage was incidental to the reported complaint and likely occurred during retraction of the device against resistance at an angle during removal 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: 16811527
• MDR Text Key: 314128788
• Report Number: 3005168196-2023-00197
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/01/2005,04/11/2024

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: F00003435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Age: 59 YR