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

Model Number CATRXKIT

Device Problems Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 09/10/2020

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 peroneal artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath and a guidewire.During the procedure, the physician placed the sheath in the contralateral femoral artery, then advanced the guidewire into the peroneal artery.While attempting to advance the catrx into the peroneal artery, the physician experienced resistance and could not advance the catrx through a previous peroneal stent that was placed six months prior.It was reported that the catrx was possibly getting stuck on the stent struts; therefore, the catrx was removed without performing aspiration.Upon removal, the physician noticed that the distal end of the catrx was kinked and stretched.The physician then ballooned the peroneal stent with a three millimeter balloon.The procedure was completed using a new catrx and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the catrx was stretched approximately 128.0 thru 134.0 cm from the hub.The total length of the catrx was 143.0 cm.The guidewire lumen had grooves in it.Conclusions: evaluation of the returned catrx confirmed that the catheter was stretched.If the catrx is forcefully retracted against resistance, damage such as a stretch may occur.Further evaluation revealed grooves along the guidewire lumen.This damage may have occurred due to catrx getting stuck on the stent as mentioned in the complaint.During the functional test, a demonstration guidewire could not be inserted through the returned catrx due to the groove along the guidewire lumen.The catrx was advanced through a demonstration benchmark without an issue.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: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10632132
• MDR Text Key: 210258763
• Report Number: 3005168196-2020-01653
• 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: 01/01/2005,09/10/2020

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: 05/07/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F97745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• 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: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 11/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR