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

Catalog Number	CAT3
Medical Device Problem Codes	Material Separation (1562); Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system cat3 aspiration catheter (cat3) was fractured approximately 13.0 cm from the hub and ovalized approximately 61.0, 83.0, 126.0, 134.0, and 146.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured and ovalized.Ovalization damage typically occurs due to improper handling during use.If the cat3 is roughly handled during insertion into the patient, ovalization may occur.Any ovalization present on the cat3 may cause difficulty advancing a guidewire through the cat3.If the guidewire is forcefully manipulated against resistance inside the cat3, it may damage the cat3 shaft.Cat3 devices are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system cat3 aspiration catheter (cat3).During the procedure, while another manufacturer's guidewire was being re-advanced through the cat3 in order to maintain access and ballooning after the aspiration process, the cat3 was penetrated and split open.The physician removed the cat3 and the guidewire from the patient and completed the procedure using a new cat3 and a new guidewire.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5383454
• Report Number: 3005168196-2016-00078
• Device Sequence Number: 18935577
• Product Code: DXE
• UDI-Device Identifier: 00814548013299
• UDI-Public: 00814548013299
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/22/2015

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
• Operator of Device: Physician
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: CAT3
• Device Lot Number: F64014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR