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

Model Number CATRXKIT

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx revealed that the guidewire lumen was damaged.This is likely the reported port that detached from the catrx.If the catrx is forcefully advanced against resistance, damage such as this may occur.The root cause of resistance could not be determined.During functional testing, resistance was encountered while advancing a demonstration guidewire wire through the guidewire lumen on the returned catrx due to coagulated blood, and the guidewire could not be advanced any further.Therefore, the catrx was not advanced through a demonstration catheter.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 in the anterior tibial (at) artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath.During the procedure, the physician completed two passes in the target vessel using the catrx.Subsequently, the physician removed the catrx to be flushed; however, while attempting to reinsert the catrx back into the valve of the sheath, the catrx would not advance and the catrx port became detached from the catheter.Therefore, the catrx was removed.The procedure was completed using another catrx and the same sheath.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy in the anterior tibial (at) artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath.During the procedure, the physician completed several passes using the catrx.Subsequently, the physician removed the catrx to be flushed; however, while attempting to reinsert the catrx back into the valve of the sheath to make another pass, the catrx would not advance and the catrx guidewire port became detached towards the distal tip of the catheter.Therefore, the catrx was removed.The procedure was completed using another catrx and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 03/08/2021: 1.Section b.Box 5.Describe event or problem.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11389135
• MDR Text Key: 233972205
• Report Number: 3005168196-2021-00362
• Device Sequence Number: 1
• Product Code: DXE
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F90917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• 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: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR