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 10/26/2022

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 posterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra lysis catheter and a non-penumbra guide sheath.During the procedure, the lysis catheter was used overnight with the guide sheath to dissolve the clot in the target vessel; however, it did not work.Therefore, the lysis catheter was removed and the catrx was advanced through the guide sheath.Subsequently, the physician noticed that the catrx was not reaching the target location and therefore attempted to advance the guide sheath more distal.It was reported that the physician had difficulty advancing the guide sheath.After advancing the guide sheath and turning aspiration on, the physician noticed air coming back.The physician checked the rhv and made sure it was tight.The physician then removed the catrx and noticed it to be kinked and broken at the proximal end.The procedure was completed with a new catrx, the same sheath and tissue plasminogen activator (tpa).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed, that the catheter was fractured.If the catrx is manipulated at an extreme angle, during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed, an unknown white residue and kinks throughout the length of the catheter shaft.These damages were incidental to the reported complaint.Penumbra products 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.H3 other text: placeholder.

• 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: 15834760
• MDR Text Key: 307838786
• Report Number: 3005168196-2022-00545
• 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
• Report Date: 01/01/2005,12/02/2022

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 Catalogue Number: CATRXKIT
• Device Lot Number: F113220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• 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: 10/26/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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: 62 YR
• Patient Sex: Male