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

Model Number 3MAXC

Device Problem Material Separation (1562)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

The end of the penumbra system® 3max¿ reperfusion catheter came apart.The patient was not harmed.The product will be sent back to penumbra for review and replacement.

• Brand Name: PENUMBRA SYSTEM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; 6262 patterson pass rd, suite a; livermore CA 94550
• MDR Report Key: 13280176
• MDR Text Key: 283950971
• Report Number: 13280176
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3MAXC
• Device Lot Number: F108621
• 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: 01/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Sex: Female