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

Catalog Number	CATD
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
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.Additional 510(k)#s that also apply to this complaint: k160533; k161523.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the subclavian vein using an indigo system catd aspiration catheter (catd).It was reported the patient¿s anatomy was tortuous.During the procedure, the physician advanced the catd through a non-penumbra sheath and over a guidewire.While advancing the catd through a tortuous tight area of the target vessel, the physician experienced resistance, and the distal end of the catd kinked; therefore, the catd was removed.The procedure was completed using another catd and the same sheath and guidewire.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATD ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9112125
• Report Number: 3005168196-2019-01804
• Device Sequence Number: 1782382
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• 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
• Report Date (Section B): 08/28/2019
• 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: Health Professional
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: CATD
• Device Lot Number: F81034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Date Report Sent to FDA: 01/01/2005