MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number CAT8XTORQ115KIT

Device Problems Decrease in Suction (1146); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

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 right superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the physician experienced resistance while advancing the cat8 through the sheath.Subsequently, the physician noticed that there was a decrease in aspiration and decided to retract the cat8 from the sheath.After retracting the cat8, the physician noticed a kink approximately two to three centimeters from the distal end of the cat8.Therefore, the cat8 was not used for the remainder of the procedure.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse affect to the patient.

Manufacturer Narrative

Evaluation of the returned cat8 revealed an ovalization in its distal shaft.This damage is likely the reported kink.If the cat8 is forcefully advanced against resistance within the non-penumbra sheath, damage such as a distal ovalization may occur.This damage likely contributed to the reported decrease in aspiration during the procedure.During functional testing, water was aspirated through the cat8 using a demonstration pump and canister without an issue.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 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12213070
• MDR Text Key: 263134426
• Report Number: 3005168196-2021-01641
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/22/2021

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: 01/30/2023
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: C23753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• 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: 06/30/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR