MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER; NRY

Catalog Number RED72SDKIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Vessel dissection is included as a possible complication in the instructions for use for the penumbra system.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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 sendit delivery device (sendit), a neuron max 6f 088 long sheath (neuron max), a balloon catheter and a guidewire.It was noted that the patient anatomy was tortuous, and the patient had a proximal ica stenosis, an additional stenosis distal to the carotid canal, and distal clot in the communicating segment of the internal carotid artery.The patient also had a dysplastic cavernous segment of the left ica.During the procedure, the physician advanced the neuron max (80cm) into the left common carotid artery and a balloon catheter was used to cross the proximal ica stenosis for angioplasty.The physician then attempted to advance the red72 with the sendit over the guidewire to the distal end of the target vessel; however, it was reported that due to tortuous anatomy and low placement of the neuron max, the red72 was unable to pass the stenotic lesion distal to the carotid canal.Therefore, the neuron max, the red72, the sendit and the guidewire were removed.The physician then advanced a longer neuron max (90cm) through the proximal left ica stenosis, and into the left cervical ica.The same red72 with the sendit was then advanced; however, the sendit could not track beyond the cavernous ica.It was reported that only the guidewire was tracked to the left m1 segment of the mca (middle cerebral artery).The physician then decided to pull the red72 and the sendit in order to take an angiographic run through the red72.When sendit was removed, the red72 came back slightly.The physician then pulled the red72 back a little more and performed an angiographic run through the red72 to see where the red72 was located.It was reported that the red72 tip was at the stenosis of the cavernous ica and was blocking the flow.The contrast from this run was observed to be stagnant in the dysplastic cavernous ica.A second "angiographic" run was then performed through the red72 without moving the catheter.During the second run, extravasation was noticed in the communicating segment of the left ica.The physician then advanced a px slim delivery microcatheter (px slim) and implanted penumbra coils 400 (pc400 coils) into the distal ica and stopped the extravasation.The procedure ended at this point.It was reported that due to multiple stenotic lesions and the catheters being occlusive proximal to the angiographic injections, plus weakened/dysplastic distal ica vessel walls, the physician speculated that this may have been a carotid blowout syndrome.

• Brand Name: PENUMBRA SYSTEM RED72 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: 17495220
• MDR Text Key: 320768340
• Report Number: 3005168196-2023-00383
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00006386
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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: 87 YR
• Patient Sex: Female