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

Model Number CATRXKIT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

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 left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx) and non-penumbra catheter.During the procedure, while advancing the catrx through the catheter in the target vessel, the physician experienced resistance, and the catrx became stuck; subsequently, the physician decided to retract the catrx.While retracting, the catrx broke at the mid-shaft; therefore, the catrx was removed.The procedure was completed with percutaneous transluminal angioplasty (pta) and stenting.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the catrx was fractured approximately 63.0 cm from the hub.The catrx was kinked approximately 20.0 cm from the distal tip.The guidewire lumen was damaged.The device had stretches from 127.5 -139.0 cm from the hub.The total length of the catrx was 144.5 cm.Conclusions: evaluation of the returned catrx confirmed that the catheter was fractured and revealed stretching on the distal shaft.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the device is retracted against resistance, damage such as stretching may occur and the kink may worsen to a fracture.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of resistance experienced during the procedure could not be determined.Further evaluation revealed a damaged guidewire lumen.This damage was likely incidental to the reported complaint and may have occurred after removal from the procedure.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 CATRX ASPIRATION CATHETER
• Type of Device: QEX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9454194
• MDR Text Key: 170456673
• Report Number: 3005168196-2019-02294
• 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: 01/01/2005,11/14/2019

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: 04/15/2021
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F82845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• 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: 11/14/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR