MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number PST2

Device Problems Crack (1135); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Aspiration catheter has a crack - did not work with suction.The product had patient contact but no patient harm.New catheter opened to complete the procedure.

• Brand Name: PENUMBRA SYSTEM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12631533
• MDR Text Key: 276389077
• Report Number: 12631533
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PST2
• Device Catalogue Number: PST2
• Device Lot Number: F98393
• 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: 09/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA