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

Catalog Number CAT6

Device Problems Kinked (1339); Physical Resistance (2578); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2016-01661.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure using indigo system aspiration catheter 6 (cat6) devices.During the procedure, while attempting to insert a cat6 into a non-penumbra sheath, the physician encountered resistance after the cat6 advanced pass the sheath¿s valve and subsequently, the cat6 became kinked.Therefore, the cat6 did not enter the sheath and was removed.The physician then attempted to insert a new cat6 into the same non-penumbra sheath.However, resistance was encountered again after the cat6 advanced pass the sheath's valve and subsequently, the cat6 became kinked.Therefore, the cat6 did not enter the sheath and was removed.It should be noted that the valve was too tight.The procedure was then completed using a new indigo system cat5 aspiration catheter (cat5).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: 6120752
• MDR Text Key: 60659344
• Report Number: 3005168196-2016-01660
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2016

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: Physician
• Device Expiration Date: 07/20/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F70718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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