MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number RED62S

Device Problem Fracture (1260)

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

Event Date 11/12/2023

Event Type  malfunction  

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 62 reperfusion catheter (red62), a non-penumbra sheath, a non-penumbra microcatheter, a non-penumbra stent retriever and a guidewire.It was noted that the patient''s anatomy was tortuous.During the procedure, while retracting the red62 after first pass aspiration, the red62 fractured mid-shaft.It was reported that the sheath was noticed to be kinked under fluoroscopy.The physician then removed the red62 with the entire system.The procedure ended at this point.The physician could not regain access once the entire system was removed.The patient was placed on comfort care and expired later that day.The cause of death was retroperitoneal hematoma.

Manufacturer Narrative

Evaluation of the returned red62 confirmed that the catheter was fractured.If the red62 is retracted against resistance, damage such as a fracture may occur.The tortuous patient anatomy and kink in the non-penumbra device likely contributed to resistance during the procedure.Further evaluation revealed ovalization and stretching on the catheter shaft.This damage was incidental to the reported complaint and the root cause 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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 18297508
• MDR Text Key: 330353854
• Report Number: 3005168196-2023-00544
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203440
• 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: 01/01/2005,12/08/2023

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: RED62S
• Device Lot Number: F00006305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• 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: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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: 91 YR
• Patient Sex: Female