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

Catalog Number CAT6

Device Problems Kinked (1339); Inadequacy of Device Shape and/or Size (1583); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2016

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.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 over a 0.35 wire and attempted to insert the cat6 into the sheath.However, while attempting to advance the cat6 through the hub of the sheath, it became kinked; therefore, the cat6 was removed.Upon inspecting the sheath, the physician noticed that it was a 6f guide instead of a 6f sheath; it was reported that the 6f guide catheter valve was too small for the cat6 and hence the crushing of the cat6.The 6f guide catheter was then removed and the procedure was completed using a 8f guide catheter and a new cat6.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 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: 6129010
• MDR Text Key: 60945183
• Report Number: 3005168196-2016-01728
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• 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: 10/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/08/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F70517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• 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: 84 YR