MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number CAT8XTORQ115

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

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: 3005168196-2017-00511, 3005168196-2017-00512.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the right common femoral vein using indigo system separator 8 (sep8) and indigo system aspiration catheter 8 (cat8) devices.During the procedure, while in use with a cat8, the distal tip of the sep8 became lodged in the chronic, organized clot in the target vessel.While the sep8 was being retracted, the soft wire distal to the bulb stretched.The physician did not mention resistance but the sep8 tip could be seen buckling against the thrombus.The sep8 was removed and the physician continued the procedure using a new sep8.While removing the new sep8 after completing a pass, the bulb of the sep8 was pulled off the wire and remained within the rotating hemostasis valve (rhv).The physician did not mention resistance while removing the sep8.The cat8 was then removed to be flushed.While an angiogram was being performed, the nurse was looping the cat8 to store on the trolley and inadvertently kinked the cat8 at the mid-shaft.Therefore, the procedure was completed using a combination of direct aspiration as well as a selection of wires to agitate the thrombus through a new cat8.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• 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: 6449637
• MDR Text Key: 71470462
• Report Number: 3005168196-2017-00513
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2017

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: Nurse
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F71999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• 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: 50 YR