MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER; NRY

Catalog Number RED43160

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

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a benchmark bmx96 access system (bmx96), sendit delivery device (sendit), penumbra system red72 reperfusion catheter (red72), and a penumbra system red 43 reperfusion catheter (red43).During the procedure, the bmx96 was advanced over a guidewire and into the mid to low cervical.Next, while advancing the red72 and sendit, the physician experienced resistance and noticed the bmx96 had fallen in the arch as the red72 and sendit was being advanced further up the carotid t segment.The physician then advanced the bmx96 over the red72 and sendit to the mid cervical but was still experiencing resistance advancing the red72 and sendit.Therefore, the physician removed the sendit device and switched to a red43.Next, while advancing the red43 and guidewire into the red72, the physician noticed the bmx96 would fall back into the arch.The bmx96 was advanced back over the red72, red43, and guidewire, but the physician experienced resistance within the bmx96.Subsequently, while attempting to pull back on the red72, red43, and guidewire, the physician still experienced resistance and fractured the red72, red43, and guidewire in the vessel.It was reported that the proximal end of the red72, red43, and guidewire were then removed.Afterwards, the physician opened a velocity and upon removal from the packaging, the physician kinked the velocity.Therefore, it was not used in the procedure.The physician opened a new velocity and attempted to remove the broken red72, red43, and guidewire using a snare device through the velocity and aspirating through the bmx96, but the broken catheters and guidewire could not be removed.The procedure had ended at this point.The patient was then taken into or and the broken red72, red43, and guidewire was removed via open surgery.

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.This report is associated with mfr report number: 1.3005168196-2023-00392 h3 other text : placeholder.

Manufacturer Narrative

Evaluation of the returned red43 confirmed a fracture and revealed stretching at the fractured location.If the red43 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Further evaluation revealed that the red43 was fractured inside the returned red72, and the distal fractured segment was stuck inside the distal segment of the fractured red72.This indicates that both devices were fractured together at the same time while retracting against resistance.The bmx96 being in the patient¿s aortic arch during manipulation may have contributed to the resistance during the procedure.Further evaluation of the red43 revealed multiples kinks on the catheter.This damage was incidental to the complaint and the root cause of this damage could not be determined.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.This report is associated with mfr report number: 1.3005168196-2023-00392 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 43 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: 17546980
• MDR Text Key: 321716059
• Report Number: 3005168196-2023-00391
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 815948025745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222808
• 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: 01/01/2005,08/30/2023

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 Expiration Date: 04/05/2024
• Device Catalogue Number: RED43160
• Device Lot Number: F00006229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• 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: 07/20/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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: 80 YR
• Patient Sex: Female