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

Catalog Number CATD

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2019

Event Type  malfunction  

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 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.

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
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8364455
• MDR Text Key: 136994832
• Report Number: 3005168196-2019-00350
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1