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

Catalog Number CAT6

Device Problems Difficult to Advance (2920); Material Deformation (2976); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the indigo system aspiration catheter (cat6) was ovalized approximately 100.0 and 112.0 cm, and crushed, folded, and ovalized approximately 134.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the cat6 was ovalized in multiple locations, and crushed on the distal tip.This damage likely occurred due to improper handling during use.If the cat6 is forcefully gripped or otherwise compressed during insertion into a sheath, the cat6 may become ovalized or otherwise damaged.The damage found on the cat6 likely prevented the sep6 from advancing, as reported in the complaint.Cat6 devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, while inserting a cat6 into the rotating hemostasis valve (rhv) of another manufacturer's sheath through the peelable sheath, the physician experienced resistance and the tip of the cat6 became stuck.The physician eventually pushed the cat6 through the sheath and positioned it in the desired location before removing the support wire.Next, the physician inserted an indigo system separator 6 (sep6) in the cat6; however, the sep6 was unable to advance out of the cat6 distal tip and therefore, the sep6 and cat6 were removed.Upon inspecting the cat6 after removal, the physician noticed its tip was pinched which prevented to sep6 from advancing through.The procedure was then completed using a new cat6 with the same sep6 and sheath.There was no report of 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5814050
• MDR Text Key: 50190041
• Report Number: 3005168196-2016-01056
• 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: K142870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 06/25/2016

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: 01/28/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F67648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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: 77 YR