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

Catalog Number CATRXKIT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using an indigo system cat rx kit.During the procedure, the physician made one pass using the indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.While advancing the catrx over the guidewire to make another pass, the physician experienced resistance; therefore, the catrx and guidewire were removed.The physician then noticed the catrx would not come off the guidewire and the catrx distal tip was found to be ovalized.The procedure was completed using a balloon angioplasty and placing a stent device.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: QEX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9452252
• MDR Text Key: 170483600
• Report Number: 3005168196-2019-02304
• Device Sequence Number: 1
• Product Code: QEX
• 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: 01/01/2005,11/15/2019

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: 05/28/2022
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F90594
• Was Device Available for Evaluation?: No
• 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: 11/15/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 123