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

Catalog Number CAT6KIT

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

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: 3005168196-2019-01141.

Event Description

The patient was undergoing a thrombectomy procedure in the right superficial femoral artery (sfa) using an indigo system cat6 aspiration catheter (cat6).During the procedure, while attempting to advance the cat6 over a guidewire through a 6fr non-penumbra sheath, the distal end of the cat6 was crushed and accordioned.Therefore, the cat6 was removed.It was reported that the physician experienced resistance while advancing the sheath.The physician then used a blade scalpel to cut the hub of the sheath to advance the new cat6.After advancing a new cat6 over a guidewire through the sheath, the physician exchanged the guidewire with an indigo system separator 6 (sep6).While using the cat6 in tandem with the sep6, the physician noticed the cat6 kinked in several places; therefore, the cat6, sep6, and sheath were removed.The procedure was completed using a new cat6, the same sep6, and a 7fr non-penumbra sheath.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: 8692719
• MDR Text Key: 147782207
• Report Number: 3005168196-2019-01142
• 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: K160533
• 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: 01/01/2005,05/13/2019

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: 01/29/2022
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F88233
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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: 54 YR