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

Model Number CAT6KIT-A

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the popliteal and tibial artery using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath.During the procedure, the physician made two passes using the cat6.While making the next pass, the physician noticed that the cat6 folded back on to itself.Therefore, the cat6 was removed out from the sheath and the physician noticed the mid shaft of the cat6 to be stretched.The procedure was completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the cat6 was ovalized approximately 36.5 ¿ 137.5 cm from the hub.Multiple kinks were present along the ovalized region.The total length was 137.5 cm.Conclusions: evaluation of the returned cat6 revealed an ovalization from the mid-shaft to the distal shaft.If the device is forcefully retracted at an extreme angle during removal from a parent device, damage such as this may occur.During functional testing, the cat6 was unable to advance through the hub of a demonstration neuron max due to the ovalization.The ovalization likely contributed to the resistance experienced during the procedure.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 ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10201470
• MDR Text Key: 196620810
• Report Number: 3005168196-2020-00831
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• 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: 01/01/2005,06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F96349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1