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

Model Number CAT6KIT-A

Device Problems Failure to Advance (2524); 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 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 was ovalized approximately 7.0 cm from the hub.The device was kinked approximately 122.0 cm from the hub.The device had multiple kinks and ovalizations approximately 127.0 cm ¿ 135.0 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed a kink.Further evaluation of the device revealed multiple kinks and ovalizations on its distal shaft.If the distal shaft of the cat6 is forcefully gripped or pinched prior to inserting the cat6 into its peel away sheath, damage such as kinks and ovalizations may occur.If the damaged cat6 is advanced through its peel away sheath or a parent device, resistance will likely be experienced, and additional kink may likely result.During functional testing, the returned cat6 was unable to advance into a demonstration peel-away sheath and neuron max due to the damage on its distal tip.Further evaluation of the device revealed a proximal ovalization.This damage was likely incidental to the complaint.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.

Event Description

The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system aspiration catheter 6 (cat6), and a non-penumbra sheath.During the procedure, a non-penumbra sheath was placed into the patient.Then, the technician attempted to advance the cat6 through the peel-away sheath; however, the cat6 would not advance through the peel-away sheath.Afterwards, the physician experienced resistance while advancing the cat6 through the hemostasis valve on the non-penumbra sheath without the use of the peel-away sheath and subsequently, the cat6 kinked approximately ten centimeters from the distal end.Therefore, the cat6 was removed.The procedure was completed using an indigo system aspiration catheter 5 (cat5) and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10766969
• MDR Text Key: 214143976
• Report Number: 3005168196-2020-01857
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F99618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• 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: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR