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

Catalog Number RED72KIT

Device Problems Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2024

Event Type  Injury  

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.

Event Description

The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced the red72 over the microcatheter through the neuron max to the target location.The microcatheter was then removed.While attempting to advance the red72 closer to the clot, the physician experienced resistance and kinked the distal length of the red72.While attempting to retract the red72 into the neuron max to relieve the slack on the red72, the physician experienced resistance and the red72 appeared to get stuck within the neuron max.It was then observed under fluoroscopy that the red72 fractured and began to unravel at the location of the kink.While removing the red72 and neuron max together, the fractured segment of the red72 detached in the aorta.The physician then made a contralateral access and used a snare device to successfully remove the fractured segment of the red72.The procedure was completed using another catheter and another sheath.

Manufacturer Narrative

Additional device code 4: 2976.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2024-00126.1.Section b.Box 5.Describe event or problem emboli is included as a possible complication in the instructions for use (ifu) for the penumbra system.Evaluation of the returned red72 confirmed a fracture.A kink and unraveled internal coil winds were present at the fractured location.If the red72 is advanced against resistance during use, damage such as a kink may occur.This kink may have contributed to the resistance experienced during retraction of the red72 through the neuron max and the kink subsequently worsened to a fracture during removal.Based on the reported event, the root cause of the resistance during advancement could not be determined.Further evaluation revealed kinks along the length of the red72.This damage was incidental to the reported complaint.The kinks on the distal fractured segment likely occurred during snaring and removal of the distal fractured segment from the patient¿s body.The kinks on the proximal fractured segment 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.

Event Description

The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced the red72 over the microcatheter through the neuron max to the target location.The microcatheter was then removed.While attempting to advance the red72 closer to the clot, the physician experienced resistance and kinked the distal length of the red72.While attempting to retract the red72 into the neuron max to relieve the slack on the red72, the physician experienced resistance and the red72 appeared to get stuck within the neuron max.It was then observed under fluoroscopy that the red72 fractured and began to unravel at the location of the kink.While removing the red72 and neuron max together, the red72 fractured.The physician then made a contralateral access and used a snare device to successfully remove the fractured segment of the red72.The procedure was completed using another catheter and another sheath.

• 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: 19059740
• MDR Text Key: 339596689
• Report Number: 3005168196-2024-00126
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023949
• UDI-Public: 815948023949
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RED72KIT
• Device Lot Number: H00003737
• Was Device Available for Evaluation?: Yes
• 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
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR