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

Catalog Number	CATD-A
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the catd was ovalized approximately 51.0 cm from the hub.A 0.088¿inch stainless steel mandrel was advanced through the hub of the catd.Resistance was encountered as the mandrel met the ovalization at the distal tip of the catheters and the mandrel advanced out of the tip with some resistance.Conclusions: evaluation of the returned catd revealed that the distal tip of the catheter was ovalized.This type of damage typically occurs due to damage in transit.If the device slips between the top and bottom packaging tray, and the packaging is forcefully gripped, damage such as this may occur.A mandrel was attempted to be advanced through both catds.However, resistance was encountered as the mandrel met the ovalization in the distal tip of the catheters and the mandrel advanced out of the distal tip with some resistance.Penumbra catheters are visually 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.
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed that the tip of the indigo system catd aspiration catheter (catd) was kinked upon opening the packaging.The damage to the catd was found prior to use, therefore, the catd 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: 7919943
• Report Number: 3005168196-2018-01924
• Device Sequence Number: 13802884
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 08/30/2018
• 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 Catalogue Number: CATD-A
• Device Lot Number: F81129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• 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: 08/30/2018
• Initial Report FDA Received Date: 09/28/2018
• 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