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

Model Number SEP8

Device Problem Defective Component (2292)

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

Event Date 12/29/2016

Event Type  malfunction  

Event Description

Patient was in o.R.For pulmonary angiography with thrombectomy.Extensive thrombectomy performed with cat 8 - completion angiography reveals improved flow dynamics and visualization of upper lobe branches with residual but decreased thrombus burden.Left pulmonary angiography reveals diminished upper lobe branches and lower lobe medial branches.Cat 8 thrombectomy was also performed primarily in lower lobar branches.No marked change in appearance noted. during the case the indigo system - separator 8 was prepped and was found that the tip was defective.The system was saved for investigation and case continued to completion.

• Brand Name: INDIGO SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6556638
• MDR Text Key: 74821820
• Report Number: 6556638
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SEP8
• Device Catalogue Number: SEP8
• Device Lot Number: F68344
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR