MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; DXE

Catalog Number CAT8TORQ85

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

Conclusion: 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 using a indigo system cat 8 aspiration catheter (cat8).During the procedure, the cat8 became kinked.The physician continued to use the kinked cat8 to completion of the procedure.There was no report of an adverse effect on the patient.

Manufacturer Narrative

The penumbra cat8 indigo system (cat8) was kinked approximately 4.5, 19.5, 21.0, 23.0, 24.0, 26.0, and 37.0 cm from the distal tip.The complaint has been evaluated.The complaint indicated that the cat8 was kinked during the procedure.The procedure was completed with the same catheter.Evaluation of the returned device confirmed the issue mentioned in the complaint.The cat8 was kinked in the proximal shaft.This type of damage typically occurs due to improper handling during use.If the device is manipulated at an angle while force is being applied, damage such as this may occur.It is likely that some of the reported damage may have occurred after the procedure was completed.These devices are 100% visually inspected for damage during process inspection.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5002331
• MDR Text Key: 22948136
• Report Number: 3005168196-2015-00783
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• 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: Physician
• Type of Report: Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/18/2018
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F64497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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