MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

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

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 was kinked approximately 1.0 cm and 9.5 cm from the hub.The distal tip was ovalized.Conclusions: evaluation of the returned cat6 revealed a kinked device.If the device is forcefully withdrawn from the packaging at extreme angles or otherwise forcefully handled, damage such as a kink may occur.Further evaluation revealed an ovalization on the distal tip.If the device is forcefully gripped or pinched, damage such as an ovalization may occur.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that an indigo system aspiration catheter 6 (cat6) was kinked upon removal from the package.The damage to the cat6 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat6.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 8076666
• MDR Text Key: 127343236
• Report Number: 3005168196-2018-02273
• Device Sequence Number: 1
• Product Code: DXE
• 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: 01/01/2005,10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• 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: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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