MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 5 ASPIRATION CATHETER; DXE

Model Number	CAT5-A
Medical Device Problem Codes	Break (1069); Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital is keeping the device for their own risk management.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right anterior tibial artery (ata) using an indigo system cat5 aspiration catheter (cat5).During the procedure, the physician advance the cat5 through a non-penumbra sheath over a spider device to the target location and began aspiration.After aspirating 3/4th of the way down the ata, the cat5 became clogged.The physician therefore removed the cat5 by retracting over the spider device and flushed the cat5.The cat5 was then re-advanced over the spider device to continue aspirating.The physician was able to aspirate more thrombus down through the ata to the arch of the foot before the cat5 needed to be flushed again.The physician removed the cat5, and upon removal found that the cat5 had broken into two pieces, and was held together only by the coil winding.The procedure ended at this point because the thrombus had been successfully removed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that additional information was provided on 02-nov-2017, as this complaint was submitted to the fda by the user facility with the following reference number: mw5072966.

• Brand Name: INDIGO SYSTEM CAT 5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7022327
• Report Number: 3005168196-2017-02014
• Device Sequence Number: 1292722
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017
• Report Date (Section F): 01/01/2005

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: 02/16/2020
• Device Model Number: CAT5-A
• Device Catalogue Number: CAT5
• Device Lot Number: F74471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 84
• Date Report Sent to FDA: 01/01/2005