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

Catalog Number CATRXKIT

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

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

Event Date 05/06/2022

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 peroneal artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.During the procedure, the physician made one pass using the catrx.The physician then made another pass using the catrx; however, while retracting after making the pass, the guidewire folded and the catrx became stuck on the folded portion of the guidewire.Consequently, the physician broke the proximal end of the catrx; therefore, the physician removed the sheath containing the broken catrx was removed.The procedure was completed using a new non-penumbra catheter and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was stretched and fractured.If the catrx is retracted against resistance, damage such as this may occur.Further evaluation revealed damage to the catrx guidewire lumen.Based on the reported complaint, the returned guidewire prolapsed while retracting the catrx through the non-penumbra sheath during the procedure.This may be experienced if the catrx guidewire lumen is advanced outside of the non-penumbra sheath being used.This likely contributed to the resistance experienced contributing to the stretch, subsequent fracture and guidewire lumen damage.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.

• 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: 14581774
• MDR Text Key: 295680689
• Report Number: 3005168196-2022-00254
• 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: 01/01/2005,08/08/2022

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: F112352
• 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: 05/06/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/08/2022
• 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: 77 YR
• Patient Sex: Female