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

Catalog Number CATRXKIT

Device Problems Material Perforation (2205); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

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.

Event Description

The patient was undergoing a thrombectomy procedure in the brachial and subclavian artery using an indigo system cat rx kit.During the procedure, while making an initial pass, the physician experienced resistance advancing and retracting an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath and, a non-penumbra guidewire into the target vessel through a stenotic area.After making two successful passes with the catrx, the physician noticed the guidewire was pushed out of the guidewire lumen of the catrx.Therefore, the physician removed the catrx and found the distal and proximal end to be kinked.The procedure was then completed using a new catrx with the same sheath and guidewire.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01650.  1.Section h.Box 6.Device code 3.Results: the catrx was kinked approximately 102.5, 112.0, 114.0, 115.5 and 116.5 cm from the hub.No puncture was observed on the guidewire lumen.Conclusions: evaluation of the returned catrx confirmed kinks.If the device is forcefully manipulated against resistance, damage such as kinks may occur.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed the guidewire lumen was only damaged at the kinked locations.The reported puncture could not be confirmed.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.Conclusion code 4316 - the investigation findings do not lead to a clear conclusion about the cause of resistance.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8936049
• MDR Text Key: 155699871
• Report Number: 3005168196-2019-01650
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• PMA/PMN Number: K163618
• 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: 01/01/2005,07/31/2019

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: 05/28/2021
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F83695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• 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: 07/31/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1