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

Model Number CATRXKIT

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath and a guidewire.During the procedure, the physician advanced the catrx into the target location which had previously placed stents and completed one pass.While retracting the catrx through the sheath after aspirating the desired area during the second pass, the physician encountered resistance; however, he continued to pull the catrx.Upon removal, the physician noticed that the rapid exchange lumen of the catrx had sheared.It was reported that the physician did not believe that the catrx was caught into a stent.The physician then ballooned the vessel.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Evaluation of the returned catrx confirmed the guidewire lumen was damaged.Evaluation revealed the guidewire lumen was damaged and open along its entire length.The complaint indicated that resistance was encountered during retraction and the physician continued to pull the catrx.Based on the length of the guidewire lumen damage, it is likely the guidewire tore out of the guidewire lumen.If the catrx is forcefully retracted against resistance, damage such as this may occur.Penumbra products 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, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12763232
• MDR Text Key: 282577329
• Report Number: 3005168196-2021-02503
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/08/2021

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 Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F107693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/12/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female