MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 5 ASPIRATION CATHETER; DXE

Catalog Number CAT5

Device Problems Device Damaged Prior to Use (2284); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint involves the sterility of a dropped device during the procedure.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.

Event Description

During preparation for a thrombectomy procedure, an indigo system cat5 aspiration catheter (cat5) was accidentally dropped on the floor after removal from the packaging.The cat5 was contaminated prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat5.

• Brand Name: INDIGO SYSTEM CAT 5 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: 8670919
• MDR Text Key: 147352872
• Report Number: 3005168196-2019-01092
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 01/01/2005,05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Catalogue Number: CAT5
• Device Lot Number: F79996
• Was Device Available for Evaluation?: No
• 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: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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