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

Model Number CATRXKIT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Fractured tip of surgical instrument (penumbra catrx) into the posterior tibial artery, successful retrieval of device catheter fragment.It was confirmed with fluoroscopy.Prolonged procedure due to attempts to retrieve fractured catheter.

• Brand Name: INDIGO SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 16060516
• MDR Text Key: 306268663
• Report Number: 16060516
• 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: 12/15/2022,11/22/2022

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: F00002074
• 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: 12/15/2022
• Date Report to Manufacturer: 12/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Sex: Female