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

Catalog Number CAT6

Device Problems Collapse (1099); Structural Problem (2506); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the indigo system aspiration catheter 6 (cat6) was kinked in multiple locations and ovalized from approximately 14.0 cm from the distal tip to the distal tip.Conclusions: evaluation of the returned device revealed the cat6 was kinked in multiple locations and ovalized in the distal shaft.This damage may have occurred due to forceful manipulation of the cat6 during insertion or advancement into a sheath.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 to treat a chronic total occlusion (cto) using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 into another manufacturer's sheath but noticed that distal end of the cat6 was crushed.Therefore, the cat6 was removed and the procedure was completed using a new cat6.It should be noted that other manufacturer's cto crossing device and atherectomy devices were also used during the procedure.There was no report of an adverse effect on 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5941043
• MDR Text Key: 54412049
• Report Number: 3005168196-2016-01299
• 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: K142870
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/19/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F69377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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
• Patient Age: 63 YR