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

Model Number CATD

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

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2019

Event Type  malfunction  

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 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.

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.

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 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
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8736403
• MDR Text Key: 149256859
• Report Number: 3005168196-2019-01233
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (y/n): Y
• PMA/PMN Number: K142870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,05/28/2019

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
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 07/22/2019; 01/14/2005
• Supplement Dates FDA Received: 08/20/2019; 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1