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

Model Number CAT6KIT-A

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

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

Event Date 08/27/2020

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 popliteal artery using an indigo system aspiration catheter 6 (cat6), non-penumbra sheath, guidewire, and support catheter.During the procedure, the physician advanced the cat6 without a peel away sheath, over the guidewire, and through the sheath.As the cat6 approached the proximal popliteal artery and anastomosis area from the bypass, the cat6 became caught in a previously placed stent and would not track through it.The physician then placed a support catheter through the cat6, but the cat6 still would not track and was getting caught on the stent.Therefore, the cat6 was removed.The physician administered tissue plasminogen activator (tpa) to the patient using a non-penumbra catheter.The procedure ended after the administration of tpa.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the device was slightly ovalized approximately 133.5 ¿ 134.5 cm from the hub, and the distal tip was damaged.Conclusions: evaluation of the returned cat6 revealed a damaged distal tip and a slight ovalization near the distal tip.This damage may have occurred due to the device getting caught on the stent during the procedure.During functional testing, the cat6 was advanced through a demonstration neuron max 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 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10553906
• MDR Text Key: 207553071
• Report Number: 3005168196-2020-01513
• 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: 01/01/2005,08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F95832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• 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: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR