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

Model Number CATRXKIT

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

Patient was undergoing a peripheral intervention in the cath lab.Dr.Requested a cat rx aspiration tubing kit.When the device was removed from the packaging, it was found to have a large kink at the end of the tubing near the hub.The equipment did not enter the patient's body.A new package was requested and used.Indigo cat rx aspiration catheter.

• Brand Name: INDIGO SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8939350
• MDR Text Key: 155809733
• Report Number: 8939350
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CATRXKIT
• Device Lot Number: F85206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA