MAUDE Adverse Event Report: PENUMBRA, INC. CAT RX KIT; CATHETER, EMBOLECTOMY

Catalog Number CATRXKIT

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

Event Type  malfunction  

Event Description

Penumbra catheter fracture on the final picture and came out of the end of the guide catheter.It was removed as a unit inspected and all parts was accounted for.X-ray showed nothing in the aorta.Catheter was packaged for inspection with lot number attached.Provider description: we elected to remove the guide liner and then deliver the penumbra device as far as we could.We perform aspiration thrombectomy which was sent by productive.We then removed the equipment to closing shots without the wire and placed a hemoband on the right ulnar side couple doses of nicardipine given as well as intracoronary nitroglycerin throughout the procedure.

• Brand Name: CAT RX KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.
• MDR Report Key: 19184679
• MDR Text Key: 341242283
• Report Number: MW5154312
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2024

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: CATRXKIT
• Device Lot Number: F00010661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White