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

Model Number CAT6KIT-A

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

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.

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the cat6 became clogged, and the physician removed the cat6.Upon removal, the mid-shaft of the cat6 was observed to be ovalized.Therefore, the cat6 was not used for the remainder of the procedure.The procedure was completed using another cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the cat6 was ovalized approximately 129.0, 131.0, and 132.5 thru 134.5 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed that the catheter was ovalized.If the peel-able sheath (provided by penumbra) is not used to the protect the distal shaft of the catheter during insertion, and the catheter is forcefully advanced against resistance, damage such as ovalization may occur.During the functional test, the cat6 was connected to a demonstration aspiration tubing, canister, and pump.The pump was powered on and fluid was aspirated into the canister.Penumbra catheters are visually inspected during in-process inspection and during quality 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: 10483875
• MDR Text Key: 211655274
• Report Number: 3005168196-2020-01359
• 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: 01/01/2005,08/14/2020

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: 04/13/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: C21160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• 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: 08/14/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 98