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

Model Number CAT6KIT-A

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a medical procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and kinked the cat6 approximately three centimeters from the distal tip.Therefore, the cat6 was removed.The procedure was completed using a new cat6.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a medical procedure using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath.During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and the cat6 became kinked approximately three centimeters from the distal tip.Therefore, the cat6 was removed.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

Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/15/2021: 1.Section b.Describe event or problem.H3 other text : placeholder.

• 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: 11093480
• MDR Text Key: 224247162
• Report Number: 3005168196-2020-02381
• 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: 01/01/2005,11/30/2020

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: 10/16/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F101197
• Was Device Available for Evaluation?: No
• 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: 11/30/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR