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

Catalog Number CATRXKIT

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

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 anterior tibial artery using a indigo system catrx aspiration catheter (catrx) from an indigo system catrx kit.During the procedure, the physician completed the first pass using the catrx.While attempting to perform the second pass, air was observed coming through the aspiration tubing (tubing).The physician withdrew the catrx from the 6f sheath and noted that the catrx was fractured proximal to the wire port.A syringe was connected to the luer lock and clot was flushed from both proximal end and distal tip of catrx.The procedure was completed using a new catrx, the same sheath and an indigo system cat6 aspiration catheter (cat6).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the indigo system catrx aspiration catheter (catrx) was kinked approximately 114.0 cm from the hub.The guide wire lumen was not torn along the catheter shaft.Conclusions: evaluation of the returned catrx revealed a kinked device.If the device is forcefully mishandled during use, damage such as a kink may occur.During functional testing, the catrx was connected to a pump max and water was aspirated through the catrx.Bubbles were observed coming through the aspiration tubing during aspiration.The kink in the catrx lumen likely contributed to the reported air coming through the aspiration tubing during the procedure.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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8847272
• MDR Text Key: 152834334
• Report Number: 3005168196-2019-01468
• 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: 01/01/2005,07/01/2019

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: 01/24/2022
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F88162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• 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: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR