MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

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

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-02110.

Event Description

During preparation for a medical procedure, a hospital staff noticed that the distal ends of two indigo system aspiration catheter 6¿s (cat6's) were kinked upon removal from the packaging.It was also noted that the cat6¿s would not flush properly.The damage to the cat6's were found prior to use, therefore, the cat6¿s were not used in the procedure.The procedure was completed using a new cat6.

Manufacturer Narrative

Results: the returned cat5 had ovalizations approximately 126.0 cm and 128.0 cm from the hub.Conclusions: evaluation of the returned cat5 revealed a device with distal ovalizations, which confirmed the customer reported kink.If the device is forcefully gripped or pinched during preparation, damage such as an ovalization may occur.During functional testing, the cat5 was able to be flushed with solution; however, the ovalizations limited flow.Penumbra catheters are 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.This report is associated with mfr report number: 3005168196-2018-02110.

Event Description

During preparation for a medical procedure, a hospital staff member noticed that the distal ends of an indigo system cat5 aspiration catheter (cat5) and an indigo system aspiration catheter 6 (cat6) were kinked upon removal from the packaging.It was also noted that the cat5 and cat6 would not flush properly.The damage to the devices were found prior to use, therefore, the devices were not used in the procedure.The procedure was completed using a new cat6.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7997259
• MDR Text Key: 124976990
• Report Number: 3005168196-2018-02109
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• 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: 01/01/2005,09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• 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: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1