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

Catalog Number SEP6

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2016

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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-00122.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure treating a thrombosed femoral/popliteal bypass graft using an indigo system aspiration catheter 6 (cat6) and an indigo system separator 6 (sep6).During the procedure, after flushing and using the cat6 multiple times, the physician inadvertently kinked the cat6 while attempting to reinsert it into a non-penumbra sheath.However, the physician continued the procedure using the kinked cat6 and the sep6; subsequently, the sep6 became kinked on both the proximal and distal shaft.Therefore, the physician removed the cat6 and sep6, changed the check-flo valve to a tuohy, and then successfully completed the procedure using a penumbra system ace 64 reperfusion catheter (ace 64).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: 6274000
• MDR Text Key: 65675910
• Report Number: 3005168196-2017-00123
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 12/31/2016

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: Physician
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: SEP6
• Device Lot Number: F67000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2016
• Initial Date FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• 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: 55 YR