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

Model Number	CATD
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2019
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.Additional 510(k) #s that also apply to this complaint: k160533, k161523.
Event or Problem Description
During preparation of a thrombectomy procedure, the hospital staff noticed that the tip of an indigo system catd aspiration catheter (catd) was flattened upon removal from the packaging.The damaged catd was found prior to use and, therefore, was not used in the procedure.The procedure was completed using a new catd.
Additional Manufacturer Narrative
Results: the catd was kinked approximately 1.5 cm from the hub.The device was ovalized from approximately 50.5 ¿ 51.5 cm from the hub.Conclusions: evaluation of the returned catd confirmed an ovalization on the distal end.If the catd distal tip becomes pinned between the two packaging trays, damage such as an ovalization may occur.Further evaluation revealed a kink near the hub.This damage was likely incidental to the reported complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2019-01233.
Event or Problem Description
During preparation of a thrombectomy procedure, the hospital staff noticed that the tip of an indigo system catd aspiration catheter (catd) was ovalized upon removal from the packaging.The damaged catd was found prior to use and, therefore, was not used in the procedure.The procedure was completed using a new catd.

• 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: 8736403
• Report Number: 3005168196-2019-01233
• Device Sequence Number: 1904950
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 05/28/2019
• 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: 12/20/2020
• Device Model Number: CATD
• Device Catalogue Number: CATD
• Device Lot Number: F81129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 01/14/2005
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/20/2019; 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005