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

Catalog Number RED72KIT

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

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

Event Date 07/14/2023

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 right m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system red 43 reperfusion catheter (red43), a neuron max 6f 088 long sheath (neuron max) and a non-penumbra short sheath.It was reported that the patient presented with tandem occlusion.During the procedure, the red72 was advanced through the neuron max and the short sheath.The physician then advanced the red43 through the red72 to the target location and completed the first pass with the red43.In order to perform the second pass, the red72 was advanced without the red43 to the target location.While retracting the red72 under aspiration from the target vessel, the physician experienced resistance and noticed under fluoroscopy that the distal mid-shaft of the red72 had become stretched and fractured.Therefore, the red72 and the neuron max were removed together.It was reported that no issue was noted with the neuron max.The physician then opened a new neuron max and attempted to advance into the same short sheath; however, the physician experienced resistance and the neuron max would not fit into the short sheath.Therefore, the neuron max was not used in the procedure.The procedure was completed using non-penumbra catheters and a stent retriever.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed that the catheter was fractured.Evaluation revealed stretching near the fractured location and the support coil winds were exposed at the fractured location.If the red72 is retracted against resistance, it may become stretched and subsequently fracture.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed stretching on the distal fractured segment.This indicates that the device likely became stuck during the procedure and may have contributed to resistance.Penumbra products are visually 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.

• 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: 17477046
• MDR Text Key: 320867776
• Report Number: 3005168196-2023-00381
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• 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,Followup
• Report Date: 01/01/2005,08/18/2023

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: RED72KIT
• Device Lot Number: H00002170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• 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: 07/14/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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 Age: 80 YR
• Patient Sex: Female