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

Model Number CATRXKIT

Device Problem Suction Failure (4039)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the catrx was kinked approximately 38.0 cm from the hub.Conclusions: evaluation of the returned catrx revealed a kink.If the catrx is forcefully mishandled at extreme angles during use, damage such as a kink may occur.During functional testing, low aspiration was observed from the catrx while attempting to aspirate water through the catheter.The kink likely contributed to the catrx's inability to aspirate during the procedure and low aspiration during the functional test.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 left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx) and aspiration tubing (tubing).During the procedure, the catrx would not aspirate when connected to the tubing.Subsequently, the physician disconnected the catrx from the tubing and discovered that the tubing would aspirate; however, the catrx would not aspirate when connected to the tubing.Therefore, the catrx was removed.The procedure was completed using a new catrx and the same tubing.There was no report of an adverse effect to the patient.

• 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: 10872004
• MDR Text Key: 217437934
• Report Number: 3005168196-2020-02043
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/29/2020

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 Expiration Date: 01/29/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F95952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• 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: 10/29/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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: 67 YR