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

Catalog Number CAT6KIT

Device Problems Stretched (1601); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 was ovalized from approximately 124.0 ¿ 129.0 cm from the hub.The total length of the cat6 was approximately 135.5 cm.Conclusions: evaluation of the returned cat6 revealed ovalizations on the distal shaft.If the cat6 is forcefully pinched or gripped prior to insertion into a parent device, damage such as ovalizations may occur.This damage may have contributed to the sudden stoppage of aspiration during the procedure.During functional testing, the cat6 was connected to a demonstration pump max and was able to aspirate liquid without an issue.The cat6 total length was measured and was within specification; therefore, the reported stretch could not be confirmed.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 superior mesenteric artery (sma) using an indigo system aspiration catheter 6 kit.During the procedure, the physician advanced the indigo system aspiration catheter 6 (cat6) into the non-penumbra sheath using the cat6 peel-away sheath.It was reported that the cat6 started to aspirate and then suddenly stopped.The physician decided to remove the cat6 and found that it was pinched and stretched.The cat6 was therefore removed and was no longer used in the procedure.The procedure was completed using a benchmark 6f 071 delivery catheter (benchmark).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: 9146729
• MDR Text Key: 161012639
• Report Number: 3005168196-2019-01839
• 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: K142870
• 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: 01/01/2005,09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F90407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2019
• 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: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• 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: 68 YR