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

Model Number CATRXKIT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the peroneal artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra guide sheath (9fr), a guidewire, a non-penumbra support catheter and another guidewire (0.014).It was reported that access had already been established in the left common femoral artery using a non-penumbra sheath and a guidewire as the patient was being dripped for the past 24 hrs prior to the procedure.During the procedure, the guidewires were exchanged using the non-penumbra support catheter in order to use the catrx.The catrx was then advanced up and over the aortic bifurcation.It was also reported that the sheath length and the patient positioning on the table created an extra turn going into the access site.The physician then noticed that he was losing wire access to the target vessel and found that the catrx and the guidewire had prolapsed into the aorta.Next, the physician attempted to advance and retract the catrx and the guidewire multiple times without success.Therefore, the physician decided to retract the catrx.The physician felt resistance while retracting and upon removal, noticed that the distal end of the catrx was missing.The physician then noticed under x-ray that the broken segment of the catrx was still on the guidewire in the patient's body.Therefore, the physician made an attempt to remove the distal end of the catrx using a snare device; however, it was unsuccessful.Subsequently, the physician used a different snare device and was able to remove the distal end of the catrx and guidewire as a single unit.The procedure was completed by ballooning the vessel multiple times.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed, that the catheter was fractured.Evaluation also revealed, the guidewire lumen was punctured.If the catheter is not sufficiently supported by the guidewire and sheath, when tracking through difficulty anatomy, the device may become kinked.Further manipulation of a kinked catheter may result in subsequent fracture of the device.Further evaluation revealed, additional fractures, multiple kinks, and stretching on the catheter shaft.This damage was likely, incidental to the reported complaint.And may have occurred, during removal from the patient.Penumbra catheters are 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.H3 other text: placeholder.

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5108157.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section e.Box 4.Initial reporter also sent report to fda.2.Section g.Box 3.Report source.

• 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: 13972299
• MDR Text Key: 288806559
• Report Number: 3005168196-2022-00144
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,05/10/2022

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: Health Professional
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F111700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• 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
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/31/2022; 04/18/2022
• Supplement Dates FDA Received: 04/26/2022; 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• 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: 66 YR
• Patient Sex: Female