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

Catalog Number CATRXKIT

Device Problems Collapse (1099); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system cat rx kit.During the procedure, the physician attempted to track the indigo system catrx aspiration catheter (catrx) over a guidewire into a previously placed stent; however, the catrx was getting caught on the stent struts.Therefore, the physician removed the catrx.Upon removal, the physician noticed that the catrx broke and frayed.Therefore, the procedure was completed using a new catrx.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the indigo system catrx aspiration catheter (catrx) was kinked on its purple strain relief and approximately 5.0 cm, 9.0 cm, 15.0 cm, 60.5 cm, 64.0 cm, 70.0 cm, 86.0 cm, 98.0 cm, 109.0 cm and 116.5 cm from the hub.The guidewire lumen was damaged and separated from the catheter on its proximal end approximately 111.5 cm from the hub.The distal tip of the catrx was disfigured approximately 140.5 cm from the hub.Conclusions: evaluation of the returned catrx confirmed the proximal end of the guidewire lumen was damaged and separated from its catheter.It was reported that the lumen was getting caught on the stent struts while advancing and retracting.This likely contributed to the observed damages to the proximal end of the guidewire lumen of the catrx.Further evaluation revealed bends along the length of the catrx.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• 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: 8355900
• MDR Text Key: 136743178
• Report Number: 3005168196-2019-00298
• 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: 01/01/2005,01/21/2019

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: 08/12/2021
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F85205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• 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: 01/21/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 100