MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Catalog Number CAT3-A

Device Problems Decrease in Suction (1146); Kinked (1339); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the indigo system cat3 aspiration catheter (cat3) was kinked in multiple locations along the distal shaft.Conclusions: evaluation of the returned device revealed it was kinked in multiple locations along the distal shaft.This damage likely occurred due to forceful manipulation of the cat3 during advancement through tortuous patient anatomy.The loss of suction reported in the complaint likely occurred due to the kinks in the distal shaft of the cat3.Penumbra catheters are 100% visually inspected during in-process inspection.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 using an indigo system aspiration catheter 3 (cat3).During the procedure, the physician advanced the cat3 through the patient's tortuous anatomy into the pedal arch and then started removing clot from the patient.However, after three passes, the physician lost suction.Therefore, the cat3 was removed.After removal of the cat3, a kink was noticed at about 3-4 centimeters from the distal tip of the cat3.The physician indicated that the cat3 may have prolapsed on itself and kinked when he was advancing it.The procedure was completed using a new cat3.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT3 ASPIRATION CATHETER
• 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: 5718219
• MDR Text Key: 47215174
• Report Number: 3005168196-2016-00788
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/21/2019
• Device Catalogue Number: CAT3-A
• Device Lot Number: F67553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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: 50 YR