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

Model Number CATRXKIT

Device Problem Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.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.

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 guidewire (bmw).During the procedure, the physician made several passes in the target location using the catrx and subsequently removed the catrx.The physician then took an angiogram and decided to make a few more passes.While attempting to reload the catrx back on the guidewire, the physician experienced resistance, and could not advance the guidewire through the rapid exchange lumen of the catrx.Therefore, the catrx was removed.The procedure was completed using a new catrx and the same guidewire.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device in complaint was not expected to be returned; however, on 10-mar-2021 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) 2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1, method code 2, and method code 3 5.Section h.Box 6: results code 1 6.Section h.Box 6.Conclusions code 1 evaluation of the returned catrx revealed that the guidewire lumen was damaged on its proximal end and the catheter was kinked proximal to the guidewire lumen.If the device is forcefully manipulated against resistance, damage such as this may occur.During functional testing, a demonstration guidewire was advanced through the guidewire lumen with minor resistance due to the damaged proximal shaft of the guidewire lumen.Further evaluation revealed an additional kink, a fracture, and additional bends.This damage was likely incidental to the reported complaint.The tubing was undamaged.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.

• 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: 11052010
• MDR Text Key: 226016327
• Report Number: 3005168196-2020-02331
• 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: 01/01/2005,11/27/2020

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: 06/24/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F99114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• 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: 11/27/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR