MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Catalog Number CAT3

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2019

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

During preparation for a thrombectomy procedure, the hospital technologist found the indigo system cat3 aspiration catheter (cat3) to be cracked upon opening the packaging.The damage to the cat3 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat3.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and is being included on this follow-up #01 mfr report:(b)(4).1.Section b.Box 5.Describe event or problem results: the indigo system cat3 aspiration catheter (cat3) was fractured approximately 35.5 cm from the hub.Yield marks were present on both sides of the fracture site.The device was ovalized approximately 149.0 cm and 149.5 cm from the hub.Conclusions: evaluation of the returned cat3 confirmed a fracture.Yield marks were present on both sides of the fracture site.This suggests that the device was kinked prior to fracture.If the device is forcefully mishandled at extreme angles during removal from its packaging hoop, damage such as a kink may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.Further evaluation revealed ovalizations on the distal tip.These damages were likely incidental to the reported complaint.Evaluation of the returned cat6 revealed multiple consecutive kinks and ovalizations on its distal end.This type of damage typically occurs if the reusable sheath is not properly utilized when advancing the cat6 into a parent device.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.This report is associated with mfr report number: (b)(4) h3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and an indigo system cat3 aspiration catheter (cat3).During the procedure, the physician made four successful passes using the cat6 with a non-penumbra sheath.The physician then removed the access sheath in exchange for a new non-penumbra sheath.However, while attempting to make a fifth pass, the physician was unable to insert the same cat6 into the new sheath using the crosscut valve and, therefore, it was removed and a new cat6 was used.Next, the hospital technician opened a cat3 and was found to be cracked.The damage to the cat3 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat3 to remove the thrombus distal in the tibial.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT3 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8571190
• MDR Text Key: 143807548
• Report Number: 3005168196-2019-00860
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• 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: 01/01/2005,04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: CAT3
• Device Lot Number: F75075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• 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: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1