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

Model Number CATRXKIT

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the catrx guidewire lumen was torn approximately 20.0 cm from its proximal end.The catrx was ovalized approximately 49.0 and 97.0 cm from the hub.Conclusions: evaluation of the returned catrx revealed that the guidewire lumen was torn.This damage likely occurred due to the technician pulling the material which was mistaken to be a wire as mentioned in the complaint.The resistance experienced while advancing the catrx through the guide catheter may have contributed to the initial material sticking out that was mistaken for a wire.Further evaluation of the returned catrx revealed that the catheter was ovalized.This damage was likely incidental to the reported complaint and may have occurred during packaging of the device for return.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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 in the saphenous vein graft using an indigo system catrx aspiration catheter (catrx) and guide catheter.During the procedure, while attempting to make the first pass, the physician experienced resistance while advancing the catrx through the guide catheter; subsequently, the catrx was unable to advance past the stenosis.Therefore, a balloon angioplasty was then performed.The physician then made another pass and was able to advance the catrx past the occlusion to remove the clot and complete the procedure.After the procedure, the hospital technician noticed approximately half an inch of a wire sticking out from the distal end of the catrx on the back table.It was reported that the hospital technician pulled the wire and the wire rolled down towards the hub of the catrx.The rest of the wire was then pulled to remove it out from the catrx.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• 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: 10519176
• MDR Text Key: 206486473
• Report Number: 3005168196-2020-01433
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• 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: 01/01/2005,08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F97411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR