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

Catalog Number CAT6KIT

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

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

The patient was undergoing a thrombectomy procedure in the tibiofibular trunk using an indigo system cat 6 aspiration catheter (cat6).During the procedure, while attempting to insert a cat6 into a non-penumbra sheath using the peel away sheath, the tip of the cat6 became came apart and unraveled; therefore, it was removed.The procedure was completed using another cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the cat6 had multiple kinks, a stretch and ovalizations from approximately 118.0 ¿ 136.0 cm.The total length of the cat6 was approximately 136.0 cm.Conclusions: evaluation of the returned cat6 revealed multiple kinks, a stretch and ovalizations along the distal shaft.If the peel away sheath provided with the cat6 is not properly utilized during insertion of the cat6 into a parent device, damages such as these may occur.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: 9090148
• MDR Text Key: 159315734
• Report Number: 3005168196-2019-01770
• 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: 01/01/2005,08/21/2019

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: 06/19/2022
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F91123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• 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: 08/21/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR