MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; DXE

Model Number SEP6

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system separator 6 (sep6), indigo system aspiration catheter 6 (cat6), and non-penumbra sheath.It was reported that the patient had a heavy thrombus burden.During the procedure, the physician completed three to four passes in the target vessel using the sep6 , cat6, and sheath.Upon removal, the sep6 started to unravel two inches back from the bulb.The entire sep6 was then removed.It was noted that the physician experienced resistance on all passes due to the thrombus burden.The procedure was completed using another sep6 and the same cat6 and sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 9849954
• MDR Text Key: 188405716
• Report Number: 3005168196-2020-00383
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/24/2020

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: SEP6
• Device Catalogue Number: SEP6
• 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: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR