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

Catalog Number CATD

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2019

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.Additional 510(k)#s that also apply to this complaint: k160533, k161523.

Event Description

During preparation for a medical procedure, the hospital staff was inspecting an indigo system catd aspiration catheter (catd) and found a kink near the distal end of the catd.The damage to the catd was found prior to use and therefore it was not used in the procedure.The procedure was completed using another catd.

Manufacturer Narrative

Results: the returned catd was kinked at approximately 41.0 cm from the hub.Conclusions: evaluation of the returned catd confirmed a kink on the distal shaft of the catheter.If the catheter is forcefully removed from the packaging tray at extreme angles or otherwise mishandled during preparation, damage such as a kink may occur.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 CATD ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8314909
• MDR Text Key: 135379337
• Report Number: 3005168196-2019-00193
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• PMA/PMN Number: K142870
• 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: 01/01/2005,01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Catalogue Number: CATD
• Device Lot Number: F83400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• 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: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1