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

Model Number CATRXKIT

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the right tibial artery using an indigo system catrx aspiration catheter (catrx), aspiration tubing (tubing), and a non-penumbra sheath.During the procedure, while advancing the catrx through the sheath, the physician initially experienced resistance but was able to track the catrx down to the posterior tibial artery.However, when aspiration was turned on, the physician noticed that there was no flow through the tubing.Subsequently, while removing the catrx, the physician experienced resistance and the proximal end of the catrx was found to be kinked.The procedure was completed using a new catrx and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx revealed a fracture.This damage was likely the reported kink.If the device is forcefully manipulated against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an ovalization on the distal shaft.If the device is forcefully pinched or gripped or is otherwise mishandled during use, damage such as an ovalization may occur.This damage may have contributed to resistance during the procedure.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.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10996564
• MDR Text Key: 221282325
• Report Number: 3005168196-2020-02250
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/17/2020

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 Expiration Date: 04/22/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F97452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• 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: 11/17/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR