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

Catalog Number CATRXKIT

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned for analysis and has been evaluated.Evaluation of the returned catrx confirmed that the catheter was fractured and revealed a kink at the fractured location.This indicates that the catrx was kinked prior to fracturing.If the catrx is advanced against resistance, damage such as a kink may occur.This kink likely contributed to the reported resistance and the catrx being stuck at the distal end of the sheath during retraction.If the catrx is retracted against this resistance, the kink may worsen to a fracture.Further evaluation revealed that the guidewire lumen was damaged at its proximal end and bends along the catheter shaft.This damage was incidental to the complaint and the root cause of this damage 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.

Event Description

The patient was undergoing a thrombectomy procedure in the tibial arteries using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.During the procedure, the physician completed 2-3 passes using the catrx.While retracting the catrx after a successful thrombectomy, the physician experienced resistance and the catrx became stuck at the distal end of the sheath.While attempting to retract the catrx, it was noticed under fluoroscopy that the catrx had fractured in half.Therefore, the physician removed the 6fr sheath with the proximal half of the catrx and the remaining fractured segment of the catrx was removed by using a snare device with a 8fr sheath.The procedure ended at this point.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2024-00161.1.Section b.Box 1.Adverse event and/or product problem.2.Section h.Box 1.Type of reportable event.3.Section h.Box 6.Patient code 1 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM CATRX 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: 19197930
• MDR Text Key: 341235955
• Report Number: 3005168196-2024-00161
• 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: K220683
• 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
• Report Date: 01/01/2005,04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F00009317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• 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: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male