MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX KIT; DXE

Catalog Number	CATRXKIT160
Medical Device Problem Codes	Kinked (1339); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system cat rx kit (kit).During the procedure, while advancing down the wire just proximal to where the rapid exchange part begins, the physician did not mention resistance; however, the indigo system cat rx aspiration catheter (catrx) became kinked and consequently, the catrx would not aspirate.Therefore, the catrx was removed and the procedure was completed using manual aspiration with another catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

• Brand Name: INDIGO SYSTEM CAT RX KIT
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6884515
• Report Number: 3005168196-2017-01616
• Device Sequence Number: 16396744
• Product Code: DXE
• UDI-Device Identifier: 00814548017587
• UDI-Public: 00814548017587
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: 04/03/2020
• Device Catalogue Number: CATRXKIT160
• Device Lot Number: C01576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1