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

Catalog Number CAT6

Device Problems Failure to Advance (2524); Physical Resistance (2578); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

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 numbers: 3005168196-2017-00387, 3005168196-2017-00388.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the portal vein, superior mesenteric vein (smv) and splenic vein using indigo aspiration system catheters 6 (cat6) and an indigo system separator 6 (sep6).During the procedure, while in use with another manufacturer¿s 6f sheath, a cat6 was removed to be flushed after being clogged.However, upon removal, the physician noticed that the cat6 was kinked around the mid-shaft area.Therefore, the cat6 was set aside and a new cat6 was opened to continue the procedure.Next, the physician added a sep6 to help clear the system; however, the sep6 distal tip kept folding on itself when it exited the cat6.The physician then requested a new sep6.Upon removing the cat6 to flush the system, the physician noticed a kink around the cat6 mid-shaft; therefore, the cat6 was set aside.The physician believe that the rotating hemostasis valve (rhv) was too tightened around both cat6¿s and did not mention resistance while using both cat6¿s.The procedure was completed using a new cat6 and a new sep6.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: 6410566
• MDR Text Key: 70125330
• Report Number: 3005168196-2017-00389
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2017

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: 03/23/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F68626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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: 14 YR