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

Catalog Number CATRXKIT

Device Problems Material Puncture/Hole (1504); Material Deformation (2976); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the catrx was kinked approximately 51.0 cm from the hub.The guidewire lumen was punctured from approximately 114.0 to 115.0 cm from the hub, approximately 25.0 cm from the distal tip.Conclusions: evaluation of the returned catrx revealed a kink on its midshaft and a tear on the guidewire lumen.If the guidewire is forcefully advanced through the guidewire lumen at extreme angles, the side lumen may become punctured.If the catrx and guidewire were attempted to be advanced into a non-penumbra guide catheter with the guidewire outside the guidewire lumen, resistance will likely be experienced.Forcefully advancing the catrx against this resistance may have resulted in the mid-shaft kink on the returned catrx.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 medical procedure using an indigo system cat rx kit.During the procedure, the indigo system cat rx (catrx) became kinked while being advanced into a non-penumbra guide catheter and, therefore, the catrx was removed.The procedure was completed using a new catrx and the same guide catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: DXE
• 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: 8029293
• MDR Text Key: 125909264
• Report Number: 3005168196-2018-02155
• Device Sequence Number: 1
• Product Code: DXE
• 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: 01/01/2005,10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F82400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• 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
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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: 65 YR
• Patient Weight: 101