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

Model Number CATRXKIT

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

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 left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx), non-penumbra guide catheter and 0.14 extra support guidewire.During the procedure, the catrx was loaded onto a support guidewire and would not advance past the rotating hemostasis valve (rhv).Subsequently, the catrx and guide catheter were removed.The physician attempted to re-advance the same catrx through a new guide catheter, but the catrx still would not advance past the rhv.Therefore, the catrx was removed.The procedure was completed using a new catrx and the second guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx revealed a puncture tear in the guidewire lumen.If a guidewire is forcefully advanced into the guidewire lumen at an extreme angle, damage such as this may occur, and resistance may be experienced during advancement.During functional testing, a demonstration guidewire was advanced through the tear in the guidewire lumen, and the catrx was attempted to be advanced through the hub of a demonstration benchmark but was unsuccessful.The guidewire was carefully advanced through the guidewire lumen, then the catrx with the guidewire within its lumen was able to advance through the benchmark without an issue.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.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11930911
• MDR Text Key: 254051389
• Report Number: 3005168196-2021-01219
• 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: 01/01/2005,06/29/2021

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: 10/02/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F100749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• 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: 05/08/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR