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

Catalog 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	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.Additional 510(k) #s that also apply to this complaint: k142870; k161523.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the tip of an indigo system aspiration catheter d (catd) was compressed upon removal from the packaging.The damage to the catd was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new catd.
Additional Manufacturer Narrative
Results: the catd was kinked approximately 13.0 cm from the hub.The catd was ovalized approximately 50.5 cm from the hub.During functional testing, resistance was encountered while attempting to advance a 0.088 stainless steel mandrel past the proximal kink in the catheter shaft, and the mandrel could not be advanced any further.Conclusions: evaluation of the returned catd revealed that the catheter was ovalized.This ovalization was likely the ¿compression¿ mentioned in the reported complaint.If the device slips between the top and bottom packaging tray and subsequently, pressure is applied to the top portion of the tray upon removal of the device from its packaging, damage such as ovalization may occur.Further evaluation of the returned catd revealed a kink.This kink was likely incidental to the reported issue and likely occurred from packaging of the device for return to penumbra.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8364455
• Report Number: 3005168196-2019-00350
• Device Sequence Number: 19311452
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 01/25/2019
• 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: 03/05/2020
• Device Catalogue Number: CATD
• Device Lot Number: F74774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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