FDA Adverse Event Malfunction Summary report: N

INDIGO SYSTEM CATRX ASPIRATION CATHETER

MDR report key: 11847501 · Received May 19, 2021

Report

Report Number: 3005168196-2021-01093
Event Type: Malfunction
Date Received: May 19, 2021
Date of Event: April 23, 2021
Report Date: June 23, 2021
Manufacturer: PENUMBRA, INC.
Product Code: QEX
UDI-DI: 00814548017556
PMA / PMN Number: K163618
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS 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.

Additional Manufacturer Narrative · 1

THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

Description of Event or Problem · 1

THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES IN THE TARGET LOCATION USING THE CATRX. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE CATRX WAS KINKED DISTALLY AFTER REMOVING THE CATRX FROM THE GUIDE CATHETER TO SEE HOW THE VESSEL LOOKED UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING A NEW CATRX AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
749027	INDIGO SYSTEM CATRX ASPIRATION CATHETER	QEX, QEW	QEX	PENUMBRA, INC.	CATRXKIT	F102655	00814548017556

Patients

Seq	Age	Sex	Outcome	Treatment
1