MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM; CATHETER, EMBOLECTOMY

Model Number CATRXKIT

Patient Problem Insufficient Information (4580)

Event Date 10/15/2023

Event Type  malfunction  

Event Description

Penumbra cat rx catheter prepped for use and possible bubbling noted when catheter submersed in water prior to use on patient.

• Brand Name: INDIGO SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 18344014
• MDR Text Key: 330784266
• Report Number: 18344014
• Device Sequence Number: 1
• Product Code: DXE
• 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: 10/26/2023

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 Catalogue Number: CATRXKIT
• Device Lot Number: F00007184
• 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: 10/26/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Weight: 83 KG