MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; QEX,QEW

Catalog Number CATRXKIT

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 05/19/2022

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 coronary artery (rca) using an indigo system catrx aspiration catheter (catrx), a guide catheter, a non-penumbra sheath and a guidewire.During the procedure, the physician made several passes using the catrx.During the final pass, the physician noticed that the hub or the back end of the catheter was bent at an acute angle.Subsequently, in an attempt to straighten the catrx, the physician broke the catrx in half.The catrx was removed from the patient.The procedure was completed using a new catrx.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was lost in transit and is no longer available for return.Therefore, 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.H3 other text : placeholder.

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured.Based on the reported event, the subject catrx was noticed to be kinked on the proximal end after several passes and subsequently fractured upon attempts to straighten the device.If the proximal end of the device is inadvertently manipulated at an angle during the procedure the device may become kinked.Further manipulation of the kinked device will likely result in the device becoming fractured.Evaluation also revealed damage to the guidewire lumen.This damage was incidental to the reported complaint and the root cause could not be determined.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.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: QEX,QEW
• 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: 14682453
• MDR Text Key: 301652344
• Report Number: 3005168196-2022-00285
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/02/2023

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 Catalogue Number: CATRXKIT
• Device Lot Number: F112353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 12/09/2022
• Supplement Dates FDA Received: 10/04/2022; 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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: 54 YR
• Patient Sex: Male