MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA INDIGO SYSTEM CAT-RX; CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number CATRXKIT

Patient Problem Insufficient Information (4580)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

Tech noted a small hole in wire when flushing during heart cath and noticed fluid leaking.Wires can be easily bent/kinked during difficult or challenging insertion, but should not have perforation in integrity of wall.

• Brand Name: PENUMBRA INDIGO SYSTEM CAT-RX
• Type of Device: CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): PENUMBRA, INC.; alameda CA 94502
• MDR Report Key: 17691957
• MDR Text Key: 322935555
• Report Number: MW5145209
• Device Sequence Number: 1
• Product Code: QEX
• 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: 08/30/2023

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 Model Number: CATRXKIT
• Device Lot Number: F00006101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic