MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ASPIRATION CATHETER; CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number CATRXKIT

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

Event Date 08/31/1923

Event Type  malfunction  

Event Description

An 86 years old undergoing a diagnostic heart catheterization procedure.Penumbra aspiration catheter snapped mid shaft and broke into pieces.Both pieces removed by the surgeon.Final angiogram performed to ensure nothing was retained.No harm to patient.Confirmed nothing was retained.Product info - penumbra cat rx "kit" indigo system aspiration tubing, ref catrxkit, lot f00006170, use by 2028-03-30.

• Brand Name: PENUMBRA ASPIRATION CATHETER
• Type of Device: CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): PENUMBRA, INC.
• MDR Report Key: 17817810
• MDR Text Key: 324336213
• Report Number: MW5146136
• Device Sequence Number: 1
• Product Code: QEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/20/2023

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 Model Number: CATRXKIT
• Device Lot Number: F0006170
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic